Germany· DE-A57-914f2da8fe90e82e
Haemonine
A medicinal product containing human coagulation factor ix, 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 Coagulation Factor Ix
- 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 coagulation factor ix in 7 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- BelgiumCofact 500 IUProthya Biosolutions Netherlands
- ItalyAIMAFIX*1 fiala EV 500 Unita' Internazionali + 1 fiala solv 10 ml + setKEDRION SpA
- SwedenImmunine 1200 IE Pulver och vätska till injektions-/infusionsvätska, lösningBaxalta Innovations GmbH
- CzechiaIMMUNINEBaxalta Innovations GmbH, Vídeň
- NorwayImmunineBaxalta Innovations GmbH
- FinlandNonafactSanquin Plasma Products B.V.
- CanadaIMMUNINE VHTAKEDA CANADA INC
Authorised across Europe · EMA
The same active substance is authorised in 24 EEA countries. Names it is sold under:
- Austria · Haemonine, Immunine
- Belgium · Octanine
- Bulgaria · Аймафикс, Имунайн
- Cyprus · Octanine
- Czechia · Immunine, Octanine F
- Estonia · Immunine, Octanine
- Spain · Factor Ix Grifols, Immunine
- Finland · Octanine
- France · Betafact, Octafix
- United Kingdom (Northern Ireland) · Alphanine, Haemonine
- Croatia · Immunine, Octanine F
- Hungary · Humafactor-9, Octanine
- Italy · Aimafix, Alphanine
- Lithuania · Immunine, Octanine
- Luxembourg · Octanine
- Latvia · Immunine, Octanine
- Malta · Aimafix, Octanine
- Norway · Immunine, Octanine
- Poland · Betafact, Immunine
- Portugal · Aimafix, Immunine
- Romania · Immunine, Octanine F
- Sweden · Immunine, Nanofix
- Slovenia · Immunine, Octanine
- Slovakia · Immunine, Octanine F
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/39a059d5-e19b-4fee-b32d-e7a42904e368 GET /v1/drugs/39a059d5-e19b-4fee-b32d-e7a42904e368?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": "Intravenous Use",
"source": "ema_art57_de",
"ma_number": null,
"substance": "Human Coagulation Factor Ix",
"atc_from_source": null,
"authorisation_country": "Germany"
}See everything about human coagulation factor ix.
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.