Iceland· IS-EU/1/22/1668/001
Roctavian
A valoctocogene roxaparvovec product containing valoctocogenum roxaparvovecum inn, registered in Iceland by BioMarin International Limited. The same ATC class is registered in 6 of our 19 countries.
Checked against Icelandic Medicines Agency (Iceland) 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: Iceland, from Icelandic Medicines Agency (Iceland)
- 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
Icelandic Medicines Agency (Iceland)- Active substance
- Valoctocogenum roxaparvovecum INN
- Manufacturer
- BioMarin International Limited
- Country
- Iceland (IS)
- ATC code
- B02BD15
- ATC class
- Valoctocogene roxaparvovec
- Reimbursed
- Not published by this register
- Source register
- Icelandic Medicines Agency (Iceland)
- Last checked
- September 8, 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
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
- IrelandROCTAVIAN 2 × 10^13 vector genomes/mL solution for infusionBiomarin 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 2 EEA countries. Names it is sold under:
- 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 Icelandic Medicines Agency (Iceland). 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/0280a1a4-08d4-4ef3-959c-c1d426b07a5c GET /v1/drugs/0280a1a4-08d4-4ef3-959c-c1d426b07a5c?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": "Innrennslislyf, lausn",
"source": "lyfjastofnun",
"atc_raw": "B02BD15",
"marketed": false,
"strength": "2 x 10e13 ferjuerfðamengi/ml",
"ma_number": "EU/1/22/1668/001",
"substance": "Valoctocogenum roxaparvovecum INN",
"other_info": "Markaðssetning á Íslandi er háð því að Lyfjastofnun hafi staðfest að sérstök skilyrði er varða öryggi og verkun við notkun lyfsins séu uppfyllt.",
"legal_status": "(R) Lyfseðilsskylt\r\n(H) Sjúkrahúsmerkt",
"ma_issued_serial": "44797"
}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.