Medicine guide
Roctavian
·
- Prescription status not stated
- Blood, clotting and anaemia
- Active substance
- Valoctocogene roxaparvovec
- Used in
- Blood, clotting and anaemia
- Made by
- BioMarin International Limited
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
- 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).
From the official label · 2026-09-30 · European Medicines Agency
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
SpainNo exact match for this strength and form
Details
| Made by | BioMarin International Limited |
|---|---|
| Active substance | Valoctocogene roxaparvovec |
| Used in | Blood, clotting and anaemia |
| Classification | B02BD15 · Blood, clotting and anaemia |
| Orphan medicine | Yes — designated for a rare disease, according to the register |
| Additional monitoring ▼ | Yes — under additional monitoring (black triangle). Report suspected side effects. |
| Authorised on | 2022-08-24 |
| Last updated by the regulator | 2026-01-14 |
| EMA product number | EMEA/H/C/005830 |
Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician
Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).