SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| NOVONORM 0.5MG TABLET | 0.5 mg | Tablet · Oral use | 30 Blister | SAR 29.15 | NCE · Prescription | NOVO NORDISK | Valid |
| NOVONORM 1MG TABLET | 1 mg | Tablet · Oral use | 30 Blister | SAR 29.15 | NCE · Prescription | NOVO NORDISK | Valid |
| NOVONORM 2MG TABLET | 2 mg | Tablet · Oral use | 30 Blister | SAR 29.15 | NCE · Prescription | NOVO NORDISK | Valid |
Indications — CHI Daman Drug Formulary
DIABETES MELLITUS TYPE 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|
| REPAGLINIDE | 0.5MG; 1MG; 2MG | tablet · oral | CHARTWELL RX | Prescription | 22 Nov 2013 |
| REPAGLINIDE | 0.5MG; 1MG; 2MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 22 Jan 2014 |
| REPAGLINIDE | 0.5MG; 1MG; 2MG | tablet · oral | MACLEODS PHARMS | Prescription | 22 Mar 2023 |
| PRANDIN | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | GEMINI LABS LLC | Discontinued | 22 Dec 1997 |
| REPAGLINIDE | 1MG; 2MG | tablet · oral | SUN PHARM INDS INC | Discontinued | 11 Jul 2013 |
| REPAGLINIDE | 0.5MG; 1MG; 2MG | tablet · oral | PADAGIS US | Discontinued | 17 Jul 2013 |
| REPAGLINIDE | 0.5MG; 1MG; 2MG | tablet · oral | QUAGEN | Discontinued | 23 Aug 2013 |
| REPAGLINIDE | 0.5MG; 1MG; 2MG | tablet · oral | ACTAVIS TOTOWA | Discontinued | 22 Jan 2014 |
| REPAGLINIDE | 0.5MG; 1MG; 2MG | tablet · oral | KENTON | Discontinued | 24 Apr 2015 |
EMA European Union — centrally authorised medicines
NovoNorm Novo Nordisk A/S · Authorised · authorised 16 Aug 1998 · ATC A10BX02
Therapeutic indication (EMA)
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Prandin Novo Nordisk A/S · Authorised · authorised 29 Jan 2001 · ATC A10BX02
Therapeutic indication (EMA)
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide Teva Teva Pharma B.V. · Authorised · authorised 28 Jun 2009 · ATC A10BX02
Therapeutic indication (EMA)
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2-diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Enyglid Krka, d.d., Novo mesto · Authorised · authorised 13 Oct 2009 · ATC A10BX02
Therapeutic indication (EMA)
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Repaglinide is also indicated in combination with metformin in type-2 diabetes patients who are not satisfactorily controlled on metformin alone. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide Krka Krka, d.d., Novo mesto · Authorised · authorised 3 Nov 2009 · ATC A10BX02
Therapeutic indication (EMA)
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Repaglinide Sun Sun Pharmaceutical Industries B.V. · Application withdrawn
Repaglinide Accord Accord Healthcare S.L.U. · Withdrawn · authorised 22 Dec 2011 · ATC A10BX02
Therapeutic indication (EMA)
Repaglinide is indicated in patients with type-2 diabetes (non-insulin-dependent diabetes mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled satisfactorily by diet, weight reduction and exercise. Treatment should be initiated as an adjunct to diet and exercise to lower the blood glucose in relation to meals.
Canada Canada — marketed products (Health Canada)
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|
| US NADAC | REPAGLINIDE 0.5 MG TABLET | $0.07724 | per EA | 23 Sep 2026 |
| US NADAC | REPAGLINIDE 1 MG TABLET | $0.09869 | per EA | 23 Sep 2026 |
| US NADAC | REPAGLINIDE 2 MG TABLET | $0.09249 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Repaglinide 1mg tablets | £46.19 | 90 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Repaglinide 2mg tablets | £35.88 | 90 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Repaglinide 500microgram tablets | £42.19 | 90 tablet | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 22 Jan 2019 PRANDIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 8 Dec 2017 PRANDIMET — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for repaglinide →
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.