Awiqli Novo Nordisk A/S · Authorised · authorised 17 May 2024 · ATC A10AE07
Therapeutic indication (EMA)
Treatment of diabetes mellitus in adults
Active substance
Insulin icodec
- SFDA 3
- US FDA 1
- EMA 1
- Health Canada 3
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Awiqli | 700 IU/ml | Solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 216.00 | Biological · Prescription | NOVO NORDISK | Valid |
| Awiqli | 700 IU/ml | Solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 648.00 | Biological · Prescription | NOVO NORDISK | Valid |
| Awiqli | 700 IU/ml | Solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 324.00 | Biological · Prescription | NOVO NORDISK | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AWIQLI FLEXTOUCH | injection · solution | NOVO NORDISK INC | Prescription | 26 Mar 2026 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
Safety signals and safety-related labeling changes
- EMA PRAC 7 May 2026 PRAC signal: Peripheral neuropathies
Action for MAH: update of the product information: No - EMA PRAC 7 May 2026 PRAC signal: Gastrointestinal volvulus
Action for MAH: update of the product information: No
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.