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Belgium· BE-AMP-SAM244885-00

Neohepatect 50 IU/ml

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

ATC J06BB04

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedNeohepatect 50 IU/mlATCJ06BB04REGISTER NO.BE-AMP-SAM244885-00PACKS LISTED1CHECKEDSeptember 26, 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: Belgium, from FAMHP / AFMPS (Belgium)
  • 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

FAMHP / AFMPS (Belgium)
Active substance
Human Hepatitis B Immunoglobulin
Manufacturer
Biotest Pharma
Country
Belgium (BE)
ATC code
J06BB04
ATC class
Hepatitis B immunoglobulin
Defined daily dose
500 E, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    3153079

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
  • 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
  • Iceland · Zutectra
  • 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 FAMHP / AFMPS (Belgium). 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/bfdfd9c4-e241-42a8-836f-b0311e0ecef7
GET /v1/drugs/bfdfd9c4-e241-42a8-836f-b0311e0ecef7?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",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Neohepatect 50 IU/ml",
  "name_fr": "Neohepatect 50 IU/ml",
  "name_nl": "Neohepatect 50 IU/ml",
  "amp_code": "SAM244885-00",
  "strengths": [
    "50.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Human Hepatitis B Immunoglobulin"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Hepatitis B Immunoglobulin",
  "authorisation_numbers": [
    "BE244885"
  ]
}
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.

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