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Germany· DE-A57-af991e0c3393b2b7

Faktor Viii Sdh Intersero

A medicinal product containing human coagulation factor viii, registered in Germany by Intersero Gmbh.

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedFaktor Viii Sdh InterseroATC—REGISTER NO.DE-A57-af991e0c3393b2…PACKS LISTED0CHECKEDSeptember 30, 2026

The record

At a glance

EMA Article 57 (European Union)
Active substance
Human Coagulation Factor Viii
Manufacturer
Intersero 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 viii in 6 other countries

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

All human coagulation factor viii products

Authorised across Europe · EMA

The same active substance is authorised in 28 EEA countries. Names it is sold under:

  • Austria · Beriate, Haemoctin Sdh
  • Belgium · Factane, Octanate
  • Bulgaria · Бериате, Емоклот
  • Cyprus · Octanate, Octanate Lv
  • Czechia · Beriate, Haemoctin Sdh
  • Denmark · Octanate Lv
  • Estonia · Beriate, Octanate
  • Spain · Beriate, Haemoctin
  • Finland · Octafil Low
  • France · Factane, Octanate
  • United Kingdom (Northern Ireland) · Fanhdi, Haemoctin
  • Greece · Fanhdi, Haemoctin
  • Croatia · Beriate, Emoclot
  • Hungary · Beriate, Fanhdi
  • Ireland · Fanhdi, Octanate
  • Italy · Beriate, Emoclot
  • Lithuania · Beriate, Octanate
  • Luxembourg · Octanate
  • Latvia · Beriate, Octanate
  • Malta · Beriate, Emoclot
  • Netherlands · Octanate, Octanate Lv
  • Norway · Octanate
  • Poland · Beriate, Emoclot
  • Portugal · Beriate, Emoclot D.I.
  • Romania · Beriate, Emoclot
  • Sweden · Octanate, Octanate Lv
  • Slovenia · Beriate, Octanate
  • Slovakia · Beriate, Octanate

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/f7c86a37-b0a2-405e-aca9-2ad928823985
GET /v1/drugs/f7c86a37-b0a2-405e-aca9-2ad928823985?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 Viii",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}

See everything about human coagulation factor viii.

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.