Ireland· IE-PA-EU/1/22/1668/001
ROCTAVIAN 2 × 10^13 vector genomes/mL solution for infusion
A valoctocogene roxaparvovec product containing valoctocogene roxaparvovec, registered in Ireland by Biomarin International Limited. The same ATC class is registered in 6 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Valoctocogene roxaparvovec is registered in 6 of 19 countries.
Countries holding a registration under ATC B02BD15 (valoctocogene roxaparvovec), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 4 of them publish a price we can compare per daily dose
Valoctocogene roxaparvovec · ATC B02BD15
6 / 19 countries
- Belgiumprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Polandprice
The record
At a glance
HPRA (Ireland)- Active substance
- Valoctocogene Roxaparvovec
- Manufacturer
- Biomarin International Limited
- Country
- Ireland (IE)
- ATC code
- B02BD15
- ATC class
- Valoctocogene roxaparvovec
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/22/1668/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Valoctocogene 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
- 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 HPRA (Ireland). 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/e25c4942-cfd5-45bb-8752-e1c23bbef67a GET /v1/drugs/e25c4942-cfd5-45bb-8752-e1c23bbef67a?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": "Solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"B02BD15"
],
"strength": null,
"pa_number": "EU/1/22/1668/001",
"substances": [
"Valoctocogene Roxaparvovec"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "24/08/2022",
"dispensing_status": "Product subject to prescription which may not be renewed (A)",
"registration_status": "AU",
"supply_legal_status": "Supply through pharmacies only",
"interchangeable_code": null
}See everything about valoctocogene 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.