Sohonos Ipsen Pharma · Refused · ATC M09AX11
Therapeutic indication (EMA)
Treatment of fibrodysplasia ossificans progressiva.
Active substance
Palovarotene
- US FDA 2
- EMA 1
- Health Canada 5
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| SOHONOS | 02524627 | 1 MG | CAPSULE · ORAL | IPSEN BIOPHARMACEUTICALS CANADA INC |
| SOHONOS | 02524635 | 1.5 MG | CAPSULE · ORAL | IPSEN BIOPHARMACEUTICALS CANADA INC |
| SOHONOS | 02524643 | 2.5 MG | CAPSULE · ORAL | IPSEN BIOPHARMACEUTICALS CANADA INC |
| SOHONOS | 02524651 | 5 MG | CAPSULE · ORAL | IPSEN BIOPHARMACEUTICALS CANADA INC |
| SOHONOS | 02524678 | 10 MG | CAPSULE · ORAL | IPSEN BIOPHARMACEUTICALS CANADA INC |
Safety signals and safety-related labeling changes
- US FDA 18 Sep 2026 SOHONOS — safety-related labeling change
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide
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.