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ROSIGLITAZONE

All products: not a benefit

Other products in the same Health Canada class (A10B, A10BG) — coverage varies; not interchangeable

  • Pioglitazone (Actos): not a benefit
  • Canagliflozin (Invokana): general benefit
  • Dapagliflozin (Forxiga): general benefit
  • Dapagliflozin + metformin (Xigduo): general benefit
  • Empagliflozin (Jardiance): general benefit
  • Empagliflozin + metformin (Synjardy): general benefit

12 more in the class list below

Rosiglitazone · DIN 02403382 · 8mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Avandia; DOSAGE FORM/ STRENGTH: 2 mg, 4 mg, 8 mg tablet — not this product; no criteria on record for this product in this block. 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 Rosiglitazone Brand(s): Avandia DOSAGE FORM/ STRENGTH: 2 mg, 4 mg, 8 mg tablet For the treatment of type 2 diabetes mellitus in patients with: • Inadequate glycemic control (HbA1c >7%) from ALL other oral antidiabetic agents* funded through one of the Ontario Drug Benefit Programs, in monotherapy or in combination OR • Where ALL other oral antidiabetic agents are inappropriate due to contraindications or intolerance AND • The patient has refused or is not able to take insulin AND • There is no known contraindication to rosiglitazone * Oral antidiabetics include the following agents;  glyburide  metformin  gliclazide (Diamicron, Diamicron MR)  sitagliptin (Januvia)  saxagliptin (Onglyza)  repaglinide (GlucoNorm)  pioglitazone (Actos) Note: A trial with acarbose is not a mandatory requirement. Note: It is not necessary for patients to have tried the following oral antidiabetic agents that are currently not funded by the OPDP for the purposes of obtaining rosiglitazone:  glimepiride (Amaryl)  nateglinide (Starlix) Duration of Approval: 5 years Renewals will be considered where patients have benefited and continue to benefit from rosiglitazone treatment as demonstrated by recent HbA1c levels ≤7% while on treatment with rosiglitazone AND in those who continue to have no known contraindication(s) to rosiglitazone. Duration of Approval: 5 years 36 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 36, record 17, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Avandia; DOSAGE FORM/ STRENGTH: 2 mg, 4 mg, 8 mg tablet — not this product; no criteria on record for this product in this block. 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 Rosiglitazone Brand(s): Avandia DOSAGE FORM/ STRENGTH: 2 mg, 4 mg, 8 mg tablet For the treatment of type 2 diabetes mellitus in patients with: • Inadequate glycemic control (HbA1c >7%) from ALL other oral antidiabetic agents* funded through one of the Ontario Drug Benefit (ODB) Programs, in monotherapy or in combination OR • Where ALL other oral antidiabetic agents are inappropriate due to contraindications or intolerance AND • The patient has refused or is not able to take insulin AND • There is no known contraindication to rosiglitazone. * Oral antidiabetics that need to be tried prior to consideration of rosiglitazone include the following agents currently reimbursed through the Ontario Public Drug Programs;  glyburide  metformin  gliclazide (Diamicron, Diamicron MR)  sitagliptin (Januvia)  repaglinide (GlucoNorm)  pioglitazone (Actos)  saxagliptin (Onglyza) Note: A trial with acarbose is not a mandatory requirement. Note: It is not necessary for patients to have tried the following oral antidiabetic agents that are currently not funded by the Ontario Public Drug Programs for the purposes of obtaining rosiglitazone: Standard Approval Duration: 5 years 472 Rosiglitazone Brand(s): Avandia DOSAGE FORM/ STRENGTH: 1 mg, 4 mg, 8 mg tablet Renewals will be considered where patients have benefited and continue to benefit from rosiglitazone treatment as demonstrated by achieving adequate glycemic control. This is shown by a recent HbA1c levels ≤7% while on treatment with rosiglitazone AND in who continue to have no known contraindication(s) to rosiglitazone. Standard Approval Duration: 5 years Palliative Care Medications NOTE: Specific products used to treat ODB-eligible patients undergoing palliative care are reimbursed under the Ontario Public Drug Programs, as Limited use benefits on the ODB formulary or through the Facilitated Access process. Under this process, a select group of participating physicians and nurse practitioners are exempt from obtaining approval under EAP on a case-by-case basis. This assumes that the prescriber has met the qualifications set by their professional associations who administer the enrollment of their members. The prescriber’s license number with their regulatory body must appear on the prescription, for purposes of verification. Palliative Care medication claims to be reimbursed by the ODB program must be prescribed in accordance with the following patient eligibility criteria: “This patient has a progressive, life-limiting illness and has chosen outpatient palliative treatment. Life expectancy of one year is applied to request durations. In order to participate in the Facilitated Access to Palliative Care Drugs process, these prescribers must be registered with their professional association as meeting the qualifications for pCFA enrollement.. For physicians this is by the Ontario Medical Association (“OMA”) and must meet pre-defined criteria the OMA sets. For nurse practitioners, this may be the NPAO or the Nurse practitioners Association of Ontario (NPAO) or the RNAO, th Registered Nurse Association of Ontario. To facilitate the reimbursement process at the pharmacy, these prescribers are asked to indicate either, “Palliative” or “P.C.F.A.” on the prescription. Prescribers who are not registered through this process must obtain approval through the Exceptional Access Program. A prescriber must provide the details of the patient’s diagnosis, current clinical status, and life expectancy. For further information regarding the list of physicians and/or the criteria physicians require to be included on the list, please contact the Ontario Medical Association: (416) 340-2234, or via email. The following products can be reimbursed for the management of patients receiving palliative care through the Telephone Request Service. Note that many Palliative Care drugs have tranoptsitioned to the ODB formulary for funding under Limited Use and do not require EAP authorization. treat ODB- 473 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 472, record 311, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Rosiglitazone · DIN 02403382 Manufacturer: A A Pharma Inc.; listing date 2017-02-28 Health Canada: Marketed since 2019-09-17 · brand ROSIGLITAZONE · ATC A10BG02 ROSIGLITAZONE · form Tablet · route Oral · ingredients ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 8 MG · company Aa pharma inc · schedule Prescription
Check this DIN again · Health Canada product record

Rosiglitazone: Formulary list price $2.7452/unit (unit not stated in source; not the patient's cost)

Ministry pays: $2.7452 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88819 · Verify on the e-Formulary ↗ (DIN 02403382)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02403382). DIN 02403382: Rosiglitazone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002018; group id 753; item number 1848; lccId None; manufacturer id AAP Source form: Tab; strength: 8mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $2.7452; ministry $2.7452 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02403382 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88819
Interchangeable products
Avandia · DIN 02241114 · not recorded
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02403382
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (68:20:02 Oral Anti-Diabetic Agents) and how they are covered

Matched class: 68:20:02 Oral Anti-Diabetic Agents

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: CANAGLIFLOZIN, DAPAGLIFLOZIN, DAPAGLIFLOZIN & METFORMIN, EMPAGLIFLOZIN, EMPAGLIFLOZIN & METFORMIN, LINAGLIPTIN, LINAGLIPTIN & METFORMIN, SAXAGLIPTIN, SAXAGLIPTIN & METFORMIN, SITAGLIPTIN, SITAGLIPTIN & METFORMIN Some products covered without a code (check the product listing): GLICLAZIDE, GLYBURIDE, METFORMIN HCL 68:20:02 Oral Anti-Diabetic Agents

PIOGLITAZONE HCL

· 30 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 15mg, 30mg, 45mg · Tab

CANAGLIFLOZIN

· 8 products · General benefit · strengths: 100mg, 300mg · Tab

DAPAGLIFLOZIN

· 22 products · General benefit · strengths: 5mg, 10mg · Tab

DAPAGLIFLOZIN & METFORMIN

· 6 products · General benefit · strengths: 5mg & 1000mg, 5mg & 850mg · Tab

EMPAGLIFLOZIN

· 2 products · General benefit · strengths: 10mg, 25mg · Tab

EMPAGLIFLOZIN & METFORMIN

· 6 products · General benefit · strengths: 5mg & 1000mg, 5mg & 500mg, 5mg & 850mg, 12.5mg & 1000mg, 12.5mg & 500mg, 12.5mg & 850mg · Tab

GLICLAZIDE

· 19 products · General benefit (18), Listed, not a benefit (1) · strengths: 60mg, 30mg, 80mg · ER Tab, SR Tab, Tab

GLYBURIDE

· 8 products · General benefit (6), Listed, not a benefit (2) · strengths: 2.5mg, 5mg · Tab

LINAGLIPTIN

· 1 products · General benefit · strengths: 5mg · Tab

LINAGLIPTIN & METFORMIN

· 3 products · General benefit · strengths: 2.5mg & 1000mg, 2.5mg & 500mg, 2.5mg & 850mg · Tab

METFORMIN HCL

· 53 products · Off-Formulary Interchangeable, not an ODB benefit (33), General benefit (19), Off-Formulary Interchangeable, not an ODB benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (1) · strengths: 500mg, 1000mg, 850mg · ER Tab, Tab

SAXAGLIPTIN

· 6 products · General benefit · strengths: 2.5mg, 5mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 68:20:02 and 6 more
Full class listing Related classes: 68:20:06 Incretin Mimetics, 68:20:10 Insulins (Rapid Acting), 68:20:12 Insulins (Intermediate Acting), 68:20:14 Insulins (Long Acting), 68:20:16 Insulins (Pre-Mixed) Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE ROSIGLITAZONE (rosiglitazone maleate) is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus for whom all other oral antidiabetic agents, in monotherapy or in combination, do not result in adequate glycemic control or are inappropriate due to contraindications or intolerance. (See WARNINGS AND PRECAUTIONS, Serious Warnings and Precautions Box and Cardiovascular). Prior to prescribing ROSIGLITAZONE, physicians must:  Document the eligibility of patients to meet the above criteria;  Counsel each patient on the risks and benefits of ROSIGLITAZONE, including the cardiovascular risks; and  Obtain the patient’s written informed consent to take the drug. In combination therapy, ROSIGLITAZONE is only indicated with metformin OR a sulfonylurea. Caloric restriction, weight loss, and exercise improve insulin sensitivity and are essential for the proper treatment of a diabetic patient. These measures are important not only in the primary treatment of type 2 diabetes, but also in maintaining the efficacy of drug therapy. Prior to initiation of therapy with ROSIGLITAZONE, secondary caus… https://pdf.hres.ca/dpd_pm/00049932.PDF PM date: not printed or not captured Source product: ROSIGLITAZONE; DIN 02403366; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
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 |
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.
Source; updated September 15, 2026

Rosiglitazone (Avandia)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of type 2 diabetes mellitus in patients with:

Ministry criteria corpus 2025-01-01; page 36

Rosiglitazone Brand(s): Avandia DOSAGE FORM/ STRENGTH: 2 mg, 4 mg, 8 mg tablet
For the treatment of type 2 diabetes mellitus in patients with:
• Inadequate glycemic control (HbA1c >7%) from ALL other oral antidiabetic agents* funded through one of the Ontario Drug Benefit Programs, in monotherapy or in combination OR
• Where ALL other oral antidiabetic agents are inappropriate due to contraindications or intolerance AND
• The patient has refused or is not able to take insulin AND
• There is no known contraindication to rosiglitazone * Oral antidiabetics include the following agents;
 glyburide
 metformin
 gliclazide (Diamicron, Diamicron MR)
 sitagliptin (Januvia)
 saxagliptin (Onglyza)
 repaglinide (GlucoNorm)
 pioglitazone (Actos) Note: A trial with acarbose is not a mandatory requirement.
Note: It is not necessary for patients to have tried the following oral antidiabetic agents that are currently not funded by the OPDP for the purposes of obtaining rosiglitazone:
 glimepiride (Amaryl)
 nateglinide (Starlix)
Duration of Approval: 5 years
Renewals will be considered where patients have benefited and continue to benefit from rosiglitazone treatment as demonstrated by recent HbA1c levels ≤7% while on treatment with rosiglitazone AND in those who continue to have no known contraindication(s) to rosiglitazone.
Duration of Approval: 5 years
36

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Rosiglitazone (Avandia)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of type 2 diabetes mellitus in patients with:

Ministry criteria corpus 2025-01-01; page 472

Rosiglitazone Brand(s): Avandia DOSAGE FORM/ STRENGTH: 2 mg, 4 mg, 8 mg tablet
For the treatment of type 2 diabetes mellitus in patients with:
• Inadequate glycemic control (HbA1c >7%) from ALL other oral antidiabetic agents* funded through one of the Ontario Drug Benefit (ODB) Programs, in monotherapy or in combination OR
• Where ALL other oral antidiabetic agents are inappropriate due to contraindications or intolerance AND
• The patient has refused or is not able to take insulin AND
• There is no known contraindication to rosiglitazone. * Oral antidiabetics that need to be tried prior to consideration of rosiglitazone include the following agents currently reimbursed through the Ontario Public Drug Programs;  glyburide  metformin  gliclazide (Diamicron, Diamicron MR)  sitagliptin (Januvia)  repaglinide (GlucoNorm)  pioglitazone (Actos)  saxagliptin (Onglyza) Note: A trial with acarbose is not a mandatory requirement. Note: It is not necessary for patients to have tried the following oral antidiabetic agents that are currently not funded by the Ontario Public Drug Programs for the purposes of obtaining rosiglitazone:
Standard Approval Duration: 5 years
472 Rosiglitazone Brand(s): Avandia DOSAGE FORM/ STRENGTH: 1 mg, 4 mg, 8 mg tablet Renewals will be considered where patients have benefited and continue to benefit from rosiglitazone treatment as demonstrated by achieving adequate glycemic control. This is shown by a recent HbA1c levels ≤7% while on treatment with rosiglitazone AND in who continue to have no known contraindication(s) to rosiglitazone.
Standard Approval Duration: 5 years
Palliative Care Medications NOTE: Specific products used to treat ODB-eligible patients undergoing palliative care are reimbursed under the Ontario Public Drug Programs, as Limited use benefits on the ODB formulary or through the Facilitated Access process. Under this process, a select group of participating physicians and nurse practitioners are exempt from obtaining approval under EAP on a case-by-case basis. This assumes that the prescriber has met the qualifications set by their professional associations who administer the enrollment of their members. The prescriber’s license number with their regulatory body must appear on the prescription, for purposes of verification.
Palliative Care medication claims to be reimbursed by the ODB program must be prescribed in accordance with the following patient eligibility criteria: “This patient has a progressive, life-limiting illness and has chosen outpatient palliative treatment. Life expectancy of one year is applied to request durations.
In order to participate in the Facilitated Access to Palliative Care Drugs process, these prescribers must be registered with their professional association as meeting the qualifications for pCFA enrollement.. For physicians this is by the Ontario Medical Association (“OMA”) and must meet pre-defined criteria the OMA sets. For nurse practitioners, this may be the NPAO or the Nurse practitioners Association of Ontario (NPAO) or the RNAO, th Registered Nurse Association of Ontario. To facilitate the reimbursement process at the pharmacy, these prescribers are asked to indicate either, “Palliative” or “P.C.F.A.” on the prescription.
Prescribers who are not registered through this process must obtain approval through the Exceptional Access Program. A prescriber must provide the details of the patient’s diagnosis, current clinical status, and life expectancy.
For further information regarding the list of physicians and/or the criteria physicians require to be included on the list, please contact the Ontario Medical Association: (416) 340-2234, or via email. The following products can be reimbursed for the management of patients receiving palliative care through the Telephone Request Service. Note that many Palliative Care drugs have tranoptsitioned to the ODB formulary for funding under Limited Use and do not require EAP authorization. treat ODB-
473

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.

Other review policies

For Rosiglitazone: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026