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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.

ATC B02

Checked against CBG-MEB (Netherlands) on

Informational only — not a medical device.

SOURCE REGISTER · NLCBG-MEB (Netherlands)normalisedRoctavian, 2 × 10¹³ vg/ml, oplossing …ATCB02REGISTER NO.NL-1463f7e20dc5PACKS LISTED1CHECKEDSeptember 29, 2026

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
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

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_id
    EU/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.

All valoctocogeen roxaparvovec products

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.