Netherlands· NL-1463f7e20dc5
Roctavian, 2 × 10¹³ vg/ml, oplossing voor infusie
A antihemorrhagics product containing valoctocogeen roxaparvovec, registered in Netherlands by BioMarin International Limited. The same ATC class is registered in 2 of our 19 countries.
Checked against CBG-MEB (Netherlands) on
Informational only — not a medical device.
Where it is registered
Valoctocogeen roxaparvovec is registered in 2 of 19 countries.
Countries holding a registration under ATC B02 (antihemorrhagics), each read from that country’s own register.
- This record: Netherlands, from CBG-MEB (Netherlands)
Valoctocogeen roxaparvovec · ATC B02
2 / 19 countries
- Ireland
- Netherlands
The record
At a glance
CBG-MEB (Netherlands)- Active substance
- VALOCTOCOGEEN ROXAPARVOVEC
- Manufacturer
- BioMarin International Limited
- Country
- Netherlands (NL)
- ATC code
- B02
- ATC class
- ANTIHEMORRHAGICS
- Reimbursed
- Not published by this register
- Source register
- CBG-MEB (Netherlands)
- Last checked
- September 29, 2026
Packs & prices · 1
- cbg_meb_idEU/1/22/1668
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Valoctocogeen 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
- SpainROCTAVIAN 2 × 10E13 GENOMAS DE VECTOR/ML SOLUCION PARA PERFUSIONBiomarin International Limited
- FinlandROCTAVIANBiomarin International Limited
- IrelandROCTAVIAN 2 × 10^13 vector genomes/mL solution for infusionBiomarin International Limited
- IcelandRoctavianBioMarin 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 CBG-MEB (Netherlands). 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/eceb263c-8b27-4644-a235-6d21a76c9ae8 GET /v1/drugs/eceb263c-8b27-4644-a235-6d21a76c9ae8?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.
{
"form": "Oplossing voor infusie",
"route": "Intraveneus gebruik",
"soort": null,
"source": "cbg_meb",
"smpc_url": "https://www.ema.europa.eu/en/documents/product-information/roctavian-epar-product-information_nl.pdf",
"strength": null,
"atc_label": "Antihemorrhagics",
"detail_url": "https://www.geneesmiddeleninformatiebank.nl/nl/cp128616",
"excipients": [
"DINATRIUMWATERSTOFFOSFAAT 12-WATER (E 339)",
"MANNITOL (D-) (E 421)",
"NATRIUMCHLORIDE",
"NATRIUMDIWATERSTOFFOSFAAT 2-WATER (E 339)",
"POLOXAMEER 188",
"WATER VOOR INJECTIE"
],
"substances": [
"VALOCTOCOGEEN ROXAPARVOVEC"
],
"leaflet_url": null,
"authorised_at": "2022/08/24",
"procedure_number": "EMEA/H/C/005830",
"dispensing_status": "Uitsluitend recept",
"registration_number": "EU/1/22/1668",
"additional_monitoring": "Y"
}See everything about valoctocogeen 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.