Medicines Substances Companies Statistics

A free, open platform for EU medicines data, based on official EMA data.

Database

Medicines
Substances
Companies

Data Sources

EMA

2026 uMedical - Open Source Project

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Roctavian

Application withdrawn

Human

Orphan medicine

Details

EMA number	EMEA/H/C/004749
ATC code	-
Authorisation	-
Revision	-

Therapeutic indication

Treatment of haemophilia A

MeSH: Hemophilia A

Group: Antihemorrhagics

Active substances

valoctocogene roxaparvovec

Marketing Authorisation Holder

BioMarin International Limited

Timeline

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Status changed: Authorised → Application withdrawn

31 Jul 2026

status_changedregulatory

Roctavian authorised

24 Aug 2022

authorisedregulatory

Roctavian | uMedical