ROCTAVIAN 2 × 10^13 vector genomes / mL solution for infusion

Licence status
Authorised: 24/08/2022
Active substances
Valoctocogene Roxaparvovec
Dosage Form
Solution for infusion
Licence number
EU/1/22/1668/001
Licence holder
Biomarin International Limited

Product documents

Licence information

ATC code
B02BD15 valoctocogene roxaparvovec
Legal supply status
Product subject to prescription which may not be renewed (A)
Place of sale
Supply through pharmacies only
Conditions of Licence
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Marketing availability
Unknown
Advertising conditions
Advertising to healthcare professionals only
Licence issued
24/08/2022