Ireland· IE-PA-EU/1/22/1715/001
Hemgenix 1 x 10^13 genome copies/mL concentrate for solution for infusion
A blood coagulation factors product containing etranacogene dezaparvovec, registered in Ireland by CSL Behring GmbH. The same ATC class is registered in 4 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Etranacogene dezaparvovec is registered in 4 of 19 countries.
Countries holding a registration under ATC B02BD (blood coagulation factors), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 2 of them publish a price we can compare per daily dose
Etranacogene dezaparvovec · ATC B02BD
4 / 19 countries
- Ireland
- Italyprice
- Netherlands
- Norwayprice
The record
At a glance
HPRA (Ireland)- Active substance
- Etranacogene dezaparvovec
- Manufacturer
- CSL Behring GmbH
- Country
- Ireland (IE)
- ATC code
- B02BD
- ATC class
- Blood coagulation factors
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/22/1715/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Etranacogene dezaparvovec in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- SwitzerlandHemgenix
- CzechiaHEMGENIXCSL Behring GmbH, Marburg
- SpainHEMGENIX 1x10E13 COPIAS DEL GENOMA/ML CONCENTRADO PARA SOLUCION PARA PERFUSIONCsl Behring Gmbh
- FinlandHemgenixCSL Behring GmbH
- FranceHEMGENIX 1 x 10 000 000 000 000 copies du génome/mL, solution à diluer pour perfusionCSL BEHRING (ALLEMAGNE)
- United KingdomHemgenix 100 tera genome copies/10ml concentrate for solution for infusion vialsCSL Behring UK Ltd
- IcelandHemgenixCSL Behring GmbH*
- NetherlandsHemgenix 1x10E13 genoomkopieën/ml concentraat voor oplossing voor infusieCSL Behring GmbH
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Hemgenix
- Liechtenstein · Hemgenix
- Norway · Hemgenix
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/3ebcce7a-f611-4ca5-9e56-e0371ac1d565 GET /v1/drugs/3ebcce7a-f611-4ca5-9e56-e0371ac1d565?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": "Concentrate for solution for infusion",
"routes": [
"Intravenous use"
],
"source": "hpra",
"atc_all": [
"B02BD"
],
"strength": null,
"pa_number": "EU/1/22/1715/001",
"substances": [
"Etranacogene dezaparvovec"
],
"legal_basis": "Full application (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "20/02/2023",
"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 etranacogene dezaparvovec.
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.