Scenesse Clinuvel Europe Limited · Authorised · authorised 22 Dec 2014 · ATC D02BB02
Therapeutic indication (EMA)
Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
Active substance
Afamelanotide
- US FDA 1
- EMA 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| SCENESSE | 16MG | implant · subcutaneous | CLIVUNEL INC | Prescription | 8 Oct 2019 |
EMA European Union — centrally authorised medicines
Safety signals and safety-related labeling changes
- US FDA 12 Aug 2024 SCENESSE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; 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.