Spain· ES:1221668001
ROCTAVIAN 2 × 10E13 GENOMAS DE VECTOR/ML SOLUCION PARA PERFUSION
A medicinal product containing valoctocogén roxaparvovec, registered in Spain by Biomarin International Limited.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- valoctocogén roxaparvovec
- Manufacturer
- Biomarin International Limited
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- June 3, 2026
Packs & prices · 0
No packs listed by the register for this record.
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Valoctocogén roxaparvovec in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumRoctavian 2 10*13 vg/mlBioMarin International
- FinlandROCTAVIANBiomarin International Limited
- IrelandROCTAVIAN 2 × 10^13 vector genomes/mL solution for infusionBiomarin International Limited
- IcelandRoctavianBioMarin International Limited
- NetherlandsRoctavian, 2 × 10¹³ vg/ml, oplossing voor infusieBioMarin International Limited
- PolandROCTAVIANBioMarin International Ltd.
- SwedenROCTAVIAN 2 x 10E13 vg/ml Infusionsvätska, lösningBioMarin International Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Roctavian
- Liechtenstein · Roctavian
- Norway · Roctavian
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of AEMPS CIMA (Spain). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/65eaecb4-d929-4176-8e68-9a0f86a09404 GET /v1/drugs/65eaecb4-d929-4176-8e68-9a0f86a09404?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1675422948000}",
"nregistro": "1221668001",
"substance": "valoctocogén roxaparvovec"
}See everything about valoctocogén roxaparvovec.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.