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Sweden· SE-20250724000051

Prothromplex 500 IE Pulver och vätska till injektionsvätska, lösning

A medicinal product containing human coagulation factor ix + human coagulation factor vii + human coagulation factor ii + human coagulation factor x, registered in Sweden by Baxalta Innovations GmbH.

Checked against Swedish Medical Products Agency (Sweden) on

Informational only — not a medical device.

SOURCE REGISTER · SESwedish Medical Products Agency (Sweden)normalisedProthromplex 500 IE Pulver och vätska…ATC—REGISTER NO.SE-20250724000051PACKS LISTED1CHECKEDOctober 1, 2026

The record

At a glance

Swedish Medical Products Agency (Sweden)
Active substance
Human Coagulation Factor Ix + Human Coagulation Factor Vii + Human Coagulation Factor Ii + Human Coagulation Factor X
Manufacturer
Baxalta Innovations GmbH
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
    20250724000051

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
  • Germany · Prothromplex 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
  • 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 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/eb2aae0f-6a0e-49ab-96b0-6ab205c8db08
GET /v1/drugs/eb2aae0f-6a0e-49ab-96b0-6ab205c8db08?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": "20250724000051",
  "product_page": "https://www.lakemedelsverket.se/sv/sok-lakemedelsfakta/lakemedel?id=20250724000051",
  "product_doc_link": "https://docetp.mpa.se/LMF/Prothromplex%20powder%20and%20solvent%20for%20solution%20for%20injection%20SmPC_09001bee84f300fe.pdf"
}

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.