Roctavian (valoctocogene roxaparvovec)
OrphanPRIMEATMPConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- valoctocogene roxaparvovec
- Company
- BioMarin International Limited
- Status
- Authorised
- CHMP opinion
- Thu 23 Jun 2022
- EU approval
- Wed 24 Aug 2022
- Designations
- Orphan, PRIME, ATMP, Conditional, Additional monitoring
- Application
- EMEA/H/C/005830
- ATC
- B02BD15
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Roctavian Application withdrawn · BioMarin International Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.