Ogsiveo Merck Europe B.V. · Authorised · authorised 14 Aug 2025 · ATC L01XX81
Therapeutic indication (EMA)
Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.
Active substance
Nirogacestat
- US FDA 2
- EMA 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- US FDA 20 Aug 2026 OGSIVEO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; 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.