Indications
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).
Composition
- Active substance
- valoctocogene roxaparvovec
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Medicine
- Roctavian
- Active substance
- valoctocogene roxaparvovec
- ATC code
- B02BD15
- Marketing authorisation holder
- BioMarin International Limited
- Status
- Authorised
- EU authorisation
- 24 Aug 2022