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Sweden· SE-20080501000130

Umanbig 180 IE/ml Injektionsvätska, lösning

A medicinal product containing human hepatitis b immunoglobulin, registered in Sweden by Kedrion S.p.A.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedUmanbig 180 IE/ml Injektionsvätska, l…ATC—REGISTER NO.SE-20080501000130PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Human Hepatitis B Immunoglobulin
Manufacturer
Kedrion S.p.A
Country
Sweden (SE)
ATC code
—
Reimbursed
Not published by this register
Source register
Swedish Medical Products Agency (Sweden)
Last checked
October 1, 2026

Packs & prices · 1

  • se_varunummer
    20080501000130

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.

All human 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
  • 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
  • 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 Swedish Medical Products Agency (Sweden). 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/428bee34-8e0f-4691-a537-362b4772f11a
GET /v1/drugs/428bee34-8e0f-4691-a537-362b4772f11a?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.

{
  "source": "lakemedelsverket",
  "doc_types": [
    "SmPC",
    "PL"
  ],
  "se_npl_id": "20080501000130",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20080501000130",
  "product_doc_link": "https://docetp.mpa.se/LMF/Umanbig%20solution%20for%20injection%20SmPC_09001bee80896f85.pdf"
}

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.