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Germany· DE-A57-a97bb9007139fe10

Prothromplex Nf

A medicinal product containing human coagulation factor ix, human coagulation factor vii, human coagulation factor ii, human coagulation factor x, registered in Germany by Takeda Gmbh.

Checked against EMA Article 57 (European Union) on

Informational only — not a medical device.

SOURCE REGISTER · DEEMA Article 57 (European Union)normalisedProthromplex NfATC—REGISTER NO.DE-A57-a97bb9007139fe…PACKS LISTED0CHECKEDSeptember 30, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about human coagulation factor ix, human coagulation factor vii, human coagulation factor ii, human coagulation factor xAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

EMA Article 57 (European Union)
Active substance
Human Coagulation Factor Ix, Human Coagulation Factor Vii, Human Coagulation Factor Ii, Human Coagulation Factor X
Manufacturer
Takeda 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, human coagulation factor vii, human coagulation factor ii, human coagulation factor x in 4 other countries

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

All human coagulation factor ix, human coagulation factor vii, human coagulation factor ii, human coagulation factor x products

Authorised across Europe · EMA

The same active substance is authorised in 23 EEA countries. Names it is sold under:

  • Austria · Prothromplex Total
  • Belgium · Prothromplex
  • Bulgaria · Протромплекс Тотал, Протромплекс Тотал Nf
  • Czechia · Prothromplex Total Nf
  • Denmark · Prothromplex
  • Estonia · Prothromplex Total
  • Spain · Prothromplex Total
  • United Kingdom (Northern Ireland) · Prothromplex Total
  • Greece · Prothromplex Total
  • Hungary · Prothromplex Total
  • Ireland · Prothromplex Total
  • Italy · Proplex
  • Lithuania · Prothromplex
  • Luxembourg · Prothromplex
  • Latvia · Prothromplex Total
  • Malta · Prothromplex Total
  • Netherlands · Prothromplex
  • Norway · Prothromplex
  • Poland · Prothromplex Total Nf
  • Portugal · Prothromplex
  • Romania · Prothromplex Total
  • Sweden · Prothromplex
  • Slovakia · Prothromplex Nf, Prothromplex Total Nf

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/7e38fcba-6af2-4ea8-9a82-55a884b1d271
GET /v1/drugs/7e38fcba-6af2-4ea8-9a82-55a884b1d271?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, Human Coagulation Factor Vii, Human Coagulation Factor Ii, Human Coagulation Factor X",
  "atc_from_source": null,
  "authorisation_country": "Germany"
}
API referenceMCP serverPlans

See everything about human coagulation factor ix, human coagulation factor vii, human coagulation factor ii, human coagulation factor x.

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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