EMA — authorised 24 August 2022
- Marketing authorisation holder: BioMarin International Limited
- Status: approved
🇪🇺 Roctavian in European Union
EMA authorised Roctavian on 24 August 2022
Marketing authorisations
EMA — authorised 24 August 2022
- Application: EMEA/H/C/005830
- Marketing authorisation holder: BioMarin International Limited
- Local brand name: Roctavian
- Indication: Treatment of severe haemophilia A (congenital factor VIII deficiency) in adult patients without a history of factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5).
- Pathway: conditional, orphan, ATMP, PRIME
- Status: approved
EMA
- Application: EMEA/H/C/004749
- Marketing authorisation holder: BioMarin International Limited
- Local brand name: Roctavian
- Indication: Treatment of haemophilia A
- Pathway: orphan
- Status: withdrawn
Roctavian in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in European Union
Frequently asked questions
Is Roctavian approved in European Union?
Yes. EMA authorised it on 24 August 2022; EMA authorised it on 24 August 2022; EMA has authorised it.
Who is the marketing authorisation holder for Roctavian in European Union?
BioMarin International Limited holds the EU marketing authorisation.