Ireland· IE-PA-EU/1/09/600/001
Zutectra 500 IU solution for injection in pre-filled syringe
A hepatitis b immunoglobulin product containing human plasma protein >96% immunoglobulins + hbs antibodies, registered in Ireland by Biotest Pharma GmbH. The same ATC class is registered in 12 of our 19 countries.
Checked against HPRA (Ireland) on
Informational only — not a medical device.
Where it is registered
Hepatitis b immunoglobulin is registered in 12 of 19 countries.
Countries holding a registration under ATC J06BB04 (hepatitis b immunoglobulin), each read from that country’s own register.
- This record: Ireland, from HPRA (Ireland)
- 7 of them publish a price we can compare per daily dose
Hepatitis b immunoglobulin · ATC J06BB04
12 / 19 countries
- Belgiumprice
- Canada
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- Norwayprice
- Polandprice
- Switzerlandprice
- United Kingdom
The record
At a glance
HPRA (Ireland)- Active substance
- Human plasma protein >96% immunoglobulins + Hbs antibodies
- Manufacturer
- Biotest Pharma GmbH
- Country
- Ireland (IE)
- ATC code
- J06BB04
- ATC class
- Hepatitis B immunoglobulin
- Defined daily dose
- 500 E, P
- Reimbursed
- Not published by this register
- Source register
- HPRA (Ireland)
- Last checked
- September 28, 2026
Packs & prices · 1
- ie_pa_numberEU/1/09/600/001
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same class
Other records under J06BB04
Hepatitis b immunoglobulin, as other registers publish it.
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/e73df200-c0c7-48c2-8beb-a0998746c39d GET /v1/drugs/e73df200-c0c7-48c2-8beb-a0998746c39d?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 injection in pre-filled syringe",
"routes": [
"Subcutaneous use"
],
"source": "hpra",
"atc_all": [
"J06BB",
"J06BB04"
],
"strength": null,
"pa_number": "EU/1/09/600/001",
"substances": [
"Human plasma protein >96% immunoglobulins",
"Hbs antibodies"
],
"legal_basis": "New active substance (Article 8(3) of Directive No 2001/83/EC)",
"market_info": "Unknown",
"authorised_at": "30/11/2009",
"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 hepatitis b immunoglobulin.
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.