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Iceland· IS-EU/1/09/600/001

Zutectra

A hepatitis b immunoglobulin product containing human hepatitis b immunoglobulin, registered in Iceland by Biotest Pharma GmbH*. The same ATC class is registered in 12 of our 19 countries.

ATC J06BB04

Checked against Icelandic Medicines Agency (Iceland) on

Informational only — not a medical device.

SOURCE REGISTER · ISIcelandic Medicines Agency (Iceland)normalisedZutectraATCJ06BB04REGISTER NO.IS-EU/1/09/600/001PACKS LISTED0CHECKEDSeptember 29, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about human hepatitis b immunoglobulinAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

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: Iceland, from Icelandic Medicines Agency (Iceland)
  • 7 of them publish a price we can compare per daily dose
Search hepatitis b immunoglobulin products by name

Hepatitis b immunoglobulin · ATC J06BB04

12 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
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

Icelandic Medicines Agency (Iceland)
Active substance
Human hepatitis B immunoglobulin
Manufacturer
Biotest Pharma GmbH*
Country
Iceland (IS)
ATC code
J06BB04
ATC class
Hepatitis B immunoglobulin
Defined daily dose
500 E, P
Reimbursed
Not published by this register
Source register
Icelandic Medicines Agency (Iceland)
Last checked
September 29, 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

Hepatitis b immunoglobulin in 7 other countries

What each register calls a product with the same active substance — salts and hydrates count as the same.

All hepatitis b immunoglobulin products

Authorised across Europe · EMA

The same active substance is authorised in 25 EEA countries. Names it is sold under:

  • Austria · Hepatect Cp, Uman Big
  • Belgium · Hepacaf, Neohepatect
  • Bulgaria · Хепатект Ср
  • Czechia · Neohepatect
  • Germany · Fovepta, Hepatect Cp
  • Denmark · Hepatect Cp, Uman Big
  • Spain · Hepatect, Igantibe
  • Finland · Hepatect
  • France · Immunoglobuline Humaine De L'hepatite B Lfb, Ivhebex
  • United Kingdom (Northern Ireland) · Hepatect Cp, Human Hepatitis B Immunoglobulin Bio Products Laboratory
  • Greece · Hepatect Cp, Venbig
  • Croatia · Hepatect Cp, Venbig
  • Hungary · Umanbig, Venbig
  • Ireland · Hepatect Cp
  • Italy · Igantibe, Immunohbs
  • Liechtenstein · Zutectra
  • Lithuania · Hepetra
  • Netherlands · Hepatect Cp, Uman Big
  • Norway · Hepatect, Umanbig
  • Poland · Gamma Anty-Hbs 200, Hepatect Cp
  • Portugal · Gammaglobulina Antihepatitis B P Behring, Hepatect Cp
  • Romania · Hepatect Cp
  • Sweden · Neohepatect, Umanbig
  • Slovenia · Hepatect Cp
  • Slovakia · Igantibe

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/5996ca7e-04c6-47b5-b24d-9412e2d449ee
GET /v1/drugs/5996ca7e-04c6-47b5-b24d-9412e2d449ee?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": "Stungulyf, lausn í áfylltri sprautu",
  "source": "lyfjastofnun",
  "atc_raw": "J06BB04",
  "marketed": false,
  "strength": "500 a.e./ml",
  "ma_number": "EU/1/09/600/001",
  "substance": "Human hepatitis B immunoglobulin",
  "other_info": null,
  "legal_status": "(R) Lyfseðilsskylt\r\n(H) Sjúkrahúsmerkt",
  "ma_issued_serial": "40233"
}
API referenceMCP serverPlans

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.

Try it freeOpen in the console