Yuviwel Ascendis Pharma Growth Disorders A/S · Opinion · ATC M05BX
Therapeutic indication (EMA)
Treatment of achondroplasia in children
Active substance
Navepegritide
- US FDA 1
- EMA 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| YUVIWEL | 1.3MG/VIAL; 2.8MG/VIAL; 5.5MG/VIAL | powder · subcutaneous | ASCENDIS | Prescription | 27 Feb 2026 |
EMA European Union — centrally authorised medicines
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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.
Updated