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Exceptional Access criteria on record are for Brand(s): GlucoNorm; DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 2 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 Repaglinide Brand(s): GlucoNorm DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 2 mg tablet For the treatment of type 2 diabetes in patients with: • Inadequate glycemic control (HbA1c >7%) using maximal* doses of a sulfonylurea AND metformin (2000mg/day) OR • Inadequate glycemic control and demonstrated intolerance or contraindication to metformin and who are on maximal* doses of a sulfonylurea OR • Inadequate glycemic control and demonstrated intolerance or contraindication to a sulfonylurea (glyburide, gliclazide or glimepiride) and are on maximal** doses of metformin OR • Demonstrated intolerance or contraindication to both a sulfonylurea (glyburide, gliclazide or glimepiride) AND metformin OR • Adequate glycemic control (HbA1c ≤ 7%) who develops intolerance or contraindication to sulfonylurea (glyburide, gliclazide or glimepiride) or metformin OR • HbA1c ≤ 7% but with greater than 50% of fasting blood glucose (FBG >7mmol/L) or post-prandial plasma glucose (PPG >10mmol/L) levels not within target range and using maximally tolerated doses of a sulfonylurea and metformin. * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10mg/day, gliclazide 160 mg/day or Diamicron MR 60 mg/day, OR glimepiride (Amaryl ) 4 mg/day. **Note: For the purpose of the EAP submission, maximal dose of metformin is considered to be 2000 mg/day Duration of Approval: 5 years 35  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 35, record 16, 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 ↗)

Auro-Repaglinide · DIN 02424274 Manufacturer: Auro Pharma Inc.; listing date 2015-01-28 Health Canada: Marketed since 2014-04-30 · brand AURO-REPAGLINIDE · ATC A10BX02 REPAGLINIDE · form Tablet · route Oral · ingredients REPAGLINIDE 2 MG · company Auro pharma inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02424274). DIN 02424274: Auro-Repaglinide Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002015; group id 752; item number 1845; lccId None; manufacturer id AUR Source form: Tab; strength: 2mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $0.2441; ministry $0.2441 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02424274 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90898

Interchangeable products

Apo-Repaglinide · DIN 02355698 · $0.2441 Co Repaglinide · DIN 02321491 · $0.2441 GlucoNorm · DIN 02239926 · not recorded Jamp Repaglinide · DIN 02354942 · $0.2441 Sandoz Repaglinide · DIN 02357488 · $0.2440

Shortage status: resolved shortage (ended 2019-10-23); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02424274

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