Regulatory PathRegulatory requirements compared

Active substance

Beremagene geperpavec

Open in the medicines table

EMA European Union — centrally authorised medicines

Vyjuvek Krystal Biotech Netherlands B.V. · Authorised · authorised 23 Apr 2025 · ATC D03AX16

Therapeutic indication (EMA)

Vyjuvek is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
VYJUVEK 5X10^9 PLAQUE FORMING UNITS/ML SUSPENSION AND GEL FOR GELPL 61095/0001KRYSTAL BIOTECH NETHERLANDS, B.V.POM

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.