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Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Jamp-Pioglitazone · DIN 02397307 Manufacturer: Jamp Pharma Corporation; listing date 2013-04-30 Health Canada: Marketed since 2025-03-04 · brand JAMP PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 15 MG · company Jamp pharma corporation · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02397307). DIN 02397307: Jamp-Pioglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002019; group id 751; item number 1840; lccId None; manufacturer id JPC Source form: Tab; strength: 15mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1.5716; ministry $1.5716 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02397307 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88227

Interchangeable products

Accel Pioglitazone · DIN 02303442 · $1.3800 Actos · DIN 02242572 · $1.5716 Apo-Pioglitazone · DIN 02302942 · $1.5716 Auro-Pioglitazone · DIN 02384906 · $1.5716 Mint-Pioglitazone · DIN 02326477 · $1.5716 Pioglitazone Hydrochloride Tablets · DIN 02391600 · $1.5716 Sandoz Pioglitazone · DIN 02297906 · $1.5716 Teva-Pioglitazone · DIN 02274914 · $1.5716 Teva-Pioglitazone · DIN 02302861 · $1.5716

Shortage status: resolved shortage (ended 2025-06-16); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02397307

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Mint-Pioglitazone · DIN 02326477 Manufacturer: Mint Pharmaceuticals Inc.; listing date 2009-11-19 Health Canada: Marketed since 2022-03-03 · brand MINT-PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 15 MG · company Mint pharmaceuticals inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02326477). DIN 02326477: Mint-Pioglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002019; group id 751; item number 1840; lccId None; manufacturer id MIN Source form: Tab; strength: 15mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1.5716; ministry $1.5716 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02326477 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81184

Interchangeable products

Accel Pioglitazone · DIN 02303442 · $1.3800 Actos · DIN 02242572 · $1.5716 Apo-Pioglitazone · DIN 02302942 · $1.5716 Auro-Pioglitazone · DIN 02384906 · $1.5716 Jamp-Pioglitazone · DIN 02397307 · $1.5716 Pioglitazone Hydrochloride Tablets · DIN 02391600 · $1.5716 Sandoz Pioglitazone · DIN 02297906 · $1.5716 Teva-Pioglitazone · DIN 02274914 · $1.5716 Teva-Pioglitazone · DIN 02302861 · $1.5716

Shortage status: resolved shortage (ended 2022-03-03); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02326477

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Pioglitazone Hydrochloride Tablets · DIN 02391600 Manufacturer: Accord Healthcare Inc.; listing date 2012-12-21 Health Canada: Marketed since 2014-10-31 · brand ACH-PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 15 MG · company Accord healthcare inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02391600). DIN 02391600: Pioglitazone Hydrochloride Tablets Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002019; group id 751; item number 1840; lccId None; manufacturer id ACH Source form: Tab; strength: 15mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1.5716; ministry $1.5716 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02391600 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87693

Interchangeable products

Accel Pioglitazone · DIN 02303442 · $1.3800 Actos · DIN 02242572 · $1.5716 Apo-Pioglitazone · DIN 02302942 · $1.5716 Auro-Pioglitazone · DIN 02384906 · $1.5716 Jamp-Pioglitazone · DIN 02397307 · $1.5716 Mint-Pioglitazone · DIN 02326477 · $1.5716 Sandoz Pioglitazone · DIN 02297906 · $1.5716 Teva-Pioglitazone · DIN 02274914 · $1.5716 Teva-Pioglitazone · DIN 02302861 · $1.5716

Shortage status: active shortage (reported 2023-10-27, last updated 2024-05-14) — report may be stale, confirm; reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02391600

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Teva-Pioglitazone · DIN 02302861 Manufacturer: Teva Canada Limited; listing date 2008-01-15 Health Canada: Marketed since 2025-12-12 · brand TEVA-PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 15 MG · company Teva canada limited · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02302861). DIN 02302861: Teva-Pioglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002019; group id 751; item number 1840; lccId None; manufacturer id TEV Source form: Tab; strength: 15mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $1.5716; ministry $1.5716 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02302861 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78818

Interchangeable products

Accel Pioglitazone · DIN 02303442 · $1.3800 Actos · DIN 02242572 · $1.5716 Apo-Pioglitazone · DIN 02302942 · $1.5716 Auro-Pioglitazone · DIN 02384906 · $1.5716 Jamp-Pioglitazone · DIN 02397307 · $1.5716 Mint-Pioglitazone · DIN 02326477 · $1.5716 Pioglitazone Hydrochloride Tablets · DIN 02391600 · $1.5716 Sandoz Pioglitazone · DIN 02297906 · $1.5716 Teva-Pioglitazone · DIN 02274914 · $1.5716

Shortage status: resolved shortage (ended 2026-01-28); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02302861

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Jamp-Pioglitazone · DIN 02365529 Manufacturer: Jamp Pharma Corporation; listing date 2011-12-15 Health Canada: Marketed since 2025-03-04 · brand JAMP PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 30 MG · company Jamp pharma corporation · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02365529). DIN 02365529: Jamp-Pioglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002020; group id 751; item number 1841; lccId None; manufacturer id JPC Source form: Tab; strength: 30mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $2.2017; ministry $2.2017 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02365529 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=85042

Interchangeable products

Accel Pioglitazone · DIN 02303450 · $1.9600 Actos · DIN 02242573 · $2.2017 Apo-Pioglitazone · DIN 02302950 · $2.2017 Auro-Pioglitazone · DIN 02384914 · $2.2017 Mint-Pioglitazone · DIN 02326485 · $2.2017 Pioglitazone Hydrochloride Tablets · DIN 02339587 · $2.2017 Sandoz Pioglitazone · DIN 02297914 · $2.2017 Teva-Pioglitazone · DIN 02274922 · $2.2017 Teva-Pioglitazone · DIN 02302888 · $2.2017

Shortage status: resolved shortage (ended 2025-06-16); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02365529

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Mint-Pioglitazone · DIN 02326485 Manufacturer: Mint Pharmaceuticals Inc.; listing date 2009-11-19 Health Canada: Marketed since 2022-03-03 · brand MINT-PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 30 MG · company Mint pharmaceuticals inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02326485). DIN 02326485: Mint-Pioglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002020; group id 751; item number 1841; lccId None; manufacturer id MIN Source form: Tab; strength: 30mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $2.2017; ministry $2.2017 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02326485 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81185

Interchangeable products

Accel Pioglitazone · DIN 02303450 · $1.9600 Actos · DIN 02242573 · $2.2017 Apo-Pioglitazone · DIN 02302950 · $2.2017 Auro-Pioglitazone · DIN 02384914 · $2.2017 Jamp-Pioglitazone · DIN 02365529 · $2.2017 Pioglitazone Hydrochloride Tablets · DIN 02339587 · $2.2017 Sandoz Pioglitazone · DIN 02297914 · $2.2017 Teva-Pioglitazone · DIN 02274922 · $2.2017 Teva-Pioglitazone · DIN 02302888 · $2.2017

Shortage status: resolved shortage (ended 2022-03-03); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02326485

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Pioglitazone Hydrochloride Tablets · DIN 02339587 Manufacturer: Accord Healthcare Inc.; listing date 2011-03-15 Health Canada: Marketed since 2014-10-31 · brand ACH-PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 30 MG · company Accord healthcare inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02339587). DIN 02339587: Pioglitazone Hydrochloride Tablets Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002020; group id 751; item number 1841; lccId None; manufacturer id ACH Source form: Tab; strength: 30mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $2.2017; ministry $2.2017 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02339587 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=82518

Interchangeable products

Accel Pioglitazone · DIN 02303450 · $1.9600 Actos · DIN 02242573 · $2.2017 Apo-Pioglitazone · DIN 02302950 · $2.2017 Auro-Pioglitazone · DIN 02384914 · $2.2017 Jamp-Pioglitazone · DIN 02365529 · $2.2017 Mint-Pioglitazone · DIN 02326485 · $2.2017 Sandoz Pioglitazone · DIN 02297914 · $2.2017 Teva-Pioglitazone · DIN 02274922 · $2.2017 Teva-Pioglitazone · DIN 02302888 · $2.2017

Shortage status: active shortage (reported 2024-12-06, last updated 2024-12-07); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02339587

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Teva-Pioglitazone · DIN 02302888 Manufacturer: Teva Canada Limited; listing date 2008-01-15 Health Canada: Marketed since 2025-12-12 · brand TEVA-PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 30 MG · company Teva canada limited · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02302888). DIN 02302888: Teva-Pioglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002020; group id 751; item number 1841; lccId None; manufacturer id TEV Source form: Tab; strength: 30mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $2.2017; ministry $2.2017 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02302888 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78819

Interchangeable products

Accel Pioglitazone · DIN 02303450 · $1.9600 Actos · DIN 02242573 · $2.2017 Apo-Pioglitazone · DIN 02302950 · $2.2017 Auro-Pioglitazone · DIN 02384914 · $2.2017 Jamp-Pioglitazone · DIN 02365529 · $2.2017 Mint-Pioglitazone · DIN 02326485 · $2.2017 Pioglitazone Hydrochloride Tablets · DIN 02339587 · $2.2017 Sandoz Pioglitazone · DIN 02297914 · $2.2017 Teva-Pioglitazone · DIN 02274922 · $2.2017

Shortage status: resolved shortage (ended 2025-11-12); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02302888

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Jamp-Pioglitazone · DIN 02365537 Manufacturer: Jamp Pharma Corporation; listing date 2011-12-15 Health Canada: Marketed since 2025-03-04 · brand JAMP PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 45 MG · company Jamp pharma corporation · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02365537). DIN 02365537: Jamp-Pioglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002021; group id 751; item number 1842; lccId None; manufacturer id JPC Source form: Tab; strength: 45mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.3105; ministry $3.3105 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02365537 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=85043

Interchangeable products

Accel Pioglitazone · DIN 02303469 · $2.9500 Actos · DIN 02242574 · $5.2710 Apo-Pioglitazone · DIN 02302977 · $3.3105 Auro-Pioglitazone · DIN 02384922 · $3.3105 Mint-Pioglitazone · DIN 02326493 · $3.3105 Pioglitazone Hydrochloride Tablets · DIN 02339595 · $3.3105 Sandoz Pioglitazone · DIN 02297922 · $3.3105 Teva-Pioglitazone · DIN 02274930 · $3.3105 Teva-Pioglitazone · DIN 02302896 · $3.3105

Shortage status: resolved shortage (ended 2025-06-16); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02365537

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Mint-Pioglitazone · DIN 02326493 Manufacturer: Mint Pharmaceuticals Inc.; listing date 2009-11-19 Health Canada: Marketed since 2022-03-03 · brand MINT-PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 45 MG · company Mint pharmaceuticals inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02326493). DIN 02326493: Mint-Pioglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002021; group id 751; item number 1842; lccId None; manufacturer id MIN Source form: Tab; strength: 45mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.3105; ministry $3.3105 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02326493 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=81186

Interchangeable products

Accel Pioglitazone · DIN 02303469 · $2.9500 Actos · DIN 02242574 · $5.2710 Apo-Pioglitazone · DIN 02302977 · $3.3105 Auro-Pioglitazone · DIN 02384922 · $3.3105 Jamp-Pioglitazone · DIN 02365537 · $3.3105 Pioglitazone Hydrochloride Tablets · DIN 02339595 · $3.3105 Sandoz Pioglitazone · DIN 02297922 · $3.3105 Teva-Pioglitazone · DIN 02274930 · $3.3105 Teva-Pioglitazone · DIN 02302896 · $3.3105

Shortage status: resolved shortage (ended 2022-03-03); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02326493

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Pioglitazone Hydrochloride Tablets · DIN 02339595 Manufacturer: Accord Healthcare Inc.; listing date 2011-03-15 Health Canada: Marketed since 2014-10-31 · brand ACH-PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 45 MG · company Accord healthcare inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02339595). DIN 02339595: Pioglitazone Hydrochloride Tablets Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002021; group id 751; item number 1842; lccId None; manufacturer id ACH Source form: Tab; strength: 45mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.3105; ministry $3.3105 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02339595 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=82519

Interchangeable products

Accel Pioglitazone · DIN 02303469 · $2.9500 Actos · DIN 02242574 · $5.2710 Apo-Pioglitazone · DIN 02302977 · $3.3105 Auro-Pioglitazone · DIN 02384922 · $3.3105 Jamp-Pioglitazone · DIN 02365537 · $3.3105 Mint-Pioglitazone · DIN 02326493 · $3.3105 Sandoz Pioglitazone · DIN 02297922 · $3.3105 Teva-Pioglitazone · DIN 02274930 · $3.3105 Teva-Pioglitazone · DIN 02302896 · $3.3105

Shortage status: active shortage (reported 2024-12-06, last updated 2024-12-07); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02339595

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

Teva-Pioglitazone · DIN 02302896 Manufacturer: Teva Canada Limited; listing date 2008-01-15 Health Canada: Marketed since 2025-12-12 · brand TEVA-PIOGLITAZONE · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 45 MG · company Teva canada limited · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02302896). DIN 02302896: Teva-Pioglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002021; group id 751; item number 1842; lccId None; manufacturer id TEV Source form: Tab; strength: 45mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.3105; ministry $3.3105 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02302896 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78820

Interchangeable products

Accel Pioglitazone · DIN 02303469 · $2.9500 Actos · DIN 02242574 · $5.2710 Apo-Pioglitazone · DIN 02302977 · $3.3105 Auro-Pioglitazone · DIN 02384922 · $3.3105 Jamp-Pioglitazone · DIN 02365537 · $3.3105 Mint-Pioglitazone · DIN 02326493 · $3.3105 Pioglitazone Hydrochloride Tablets · DIN 02339595 · $3.3105 Sandoz Pioglitazone · DIN 02297922 · $3.3105 Teva-Pioglitazone · DIN 02274930 · $3.3105

Shortage status: resolved shortage (ended 2025-01-14); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02302896

Shortage record checked 2026-09-13T08:10:21.292534+00:00