Valoctocogene roxaparvovec

Roctavian, 2 × 10¹³ vg/ml, oplossing voor infusie

Oplossing voor infusieNetherlandsAuthorisedAuthorised 24 Aug 2022

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

RoctavianEuropean UnionAuthorised

Roctavian 2 × 10E13 Genomas de Vector/ML Solucion Para PerfusionSpain · 2x10E13 vg/ml · solución para perfusión · Biomarin International LimitedSame brand
RoctavianEuropean Union · BioMarin International LimitedSame brand
RoctavianEuropean Union · BioMarin International LimitedSame brand
RoctavianUnited States · 16X 10E13GENOMES PER ML · Injection · Biomarin Pharmaceutical Inc.Same brand

Documents

The official texts, at the regulator.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

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Valoctocogene roxaparvovec

Roctavian, 2 × 10¹³ vg/ml, oplossing voor infusie

Oplossing voor infusieNetherlandsAuthorisedAuthorised 24 Aug 2022

Product informationAsk Osler about it

In other countries

The same active substances on other registers, the same brand first.

Authorised centrally in the EU

This national listing belongs to a medicine the European Commission authorised for the whole EU.

RoctavianEuropean UnionAuthorised

Documents

The official texts, at the regulator.

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Discover Osler

Summary of product characteristicsCBG-MEB

Register entryCBG-MEB

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

College ter Beoordeling van Geneesmiddelen

College ter Beoordeling van Geneesmiddelen, Geneesmiddeleninformatiebank metadata, source update 07-10-2026; downloaded 08-10-2026; factual adaptation.

Licence: Conditional noncreative administrative factual metadata; no dataset-wide CC0 claim · Added 8 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

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

Active substance: Valoctocogene roxaparvovec
Dosage form: Oplossing voor infusie
Route: Intraveneus gebruik
Register: Netherlands (CBG-MEB)
Status: Authorised
Status in the register: Ingeschreven
Authorised: 24 Aug 2022
Registration: EU/1/22/1668
Marketing authorisation holder: BioMarin International Limited
ATC code: B02
Group: Blood and blood-forming organs
Procedure: EU centralised
Supply: Uitsluitend recept
EMA product number: EMEA/H/C/005830
EU number: EU/1/22/1668