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.
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_varunummer20250724000051
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.
- CzechiaOCPLEXOctapharma (IP) SPRL, Anderlecht
- IrelandOctaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusionHuman Prothrombin ComplexOctapharma (IP)
- GermanyProthromplex NfTakeda Gmbh
- NorwayProthromplexBaxalta Innovations GmbH
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.