Germany· DE-A57-db77a0f585886ee9
Fovepta
A medicinal product containing human hepatitis b immunoglobulin, registered in Germany by Biotest Pharma Gmbh.
Checked against EMA Article 57 (European Union) on
Informational only — not a medical device.
The record
At a glance
EMA Article 57 (European Union)- Active substance
- Human Hepatitis B Immunoglobulin
- Manufacturer
- Biotest Pharma Gmbh
- Country
- Germany (DE)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- EMA Article 57 (European Union)
- Last checked
- September 30, 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
Human 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.
- BelgiumHepacaf 5000 IULFB BIOMEDICAMENTS
- NorwayHepatectBiotest Pharma GmbH
- United StatesHepaGam BKamada Ltd.
- SwedenNeohepatect 50 IE/ml Infusionsvätska, lösningBiotest Pharma GmbH
- FinlandImmunogamCangene Europe Limited
- CzechiaZUTECTRABiotest Pharma GmbH, Dreieich
- IcelandZutectraBiotest Pharma GmbH*
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
- 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 EMA Article 57 (European Union). 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/b4bf0372-1555-447f-9f41-2d5859502a2e GET /v1/drugs/b4bf0372-1555-447f-9f41-2d5859502a2e?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.
{
"pzn": null,
"route": "Intramuscular Use ,Subcutaneous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Human Hepatitis B Immunoglobulin",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about human 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.