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Belgium· BE-AMP-SAM188431-00

PPSB Solvent Detergent Rode Kruis

A coagulation factor ix, ii, vii and x in combination product containing human coagulation factor ix, registered in Belgium by Prothya Biosolutions Belgium. The same ATC class is registered in 11 of our 19 countries.

ATC B02BD01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedPPSB Solvent Detergent Rode KruisATCB02BD01REGISTER NO.BE-AMP-SAM188431-00PACKS LISTED1CHECKEDSeptember 26, 2026

Where it is registered

Coagulation factor ix, ii, vii and x in combination is registered in 11 of 19 countries.

Countries holding a registration under ATC B02BD01 (coagulation factor ix, ii, vii and x in combination), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 7 of them publish a price we can compare per daily dose

Coagulation factor ix, ii, vii and x in combination · ATC B02BD01

11 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Icelandprice
  • Ireland
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
Blue: a registration under this ATC code. The ringed marker is this record’s country. Markets marked price publish a price we can compare per daily dose.

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Human Coagulation Factor IX
Manufacturer
Prothya Biosolutions Belgium
Country
Belgium (BE)
ATC code
B02BD01
ATC class
Coagulation factor IX, II, VII and X in combination
Defined daily dose
1.6 TSD, E
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 1

  • be_apb
    2834133

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Interactions

3 interactions on record for coagulation factor ix, ii, vii and x in combination.

Graded by severity as the source publishes them — 2 severe. Severity grades are free for everyone; mechanism and management come with Growth.

  • Severity for every pair — free, no plan needed
  • The source, licence and sync date on every record
  • Mechanism and what to do for each pair — Growth plan

Coagulation factor ix, ii, vii and x in combination · interactions on record

3 records

  • 2 severe
  • 1 moderate

Most severe, free to view

  • CarfilzomibL01XG02severe
  • CarfilzomibL01XX45severe
  • PegvaliaseA16AB19moderate
  • Interaction severity from DDInter 2.0 (Xiong G. et al., Nucleic Acids Res.), licensed CC BY-NC 4.0 — free for non-commercial use only; not covered by the Drug Database commercial licence.
Mechanism and what to do, in the interaction check
Source: DDInter 2.0 · synced 29 Sept 2026. Grades as the source publishes them.

Same medicine, other countries

Coagulation factor ix, ii, vii and x in combination in 7 other countries

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

All coagulation factor ix, ii, vii and x in combination products

Authorised across Europe · EMA

The same active substance is authorised in 24 EEA countries. Names it is sold under:

  • Austria · Haemonine, Immunine
  • Bulgaria · Аймафикс, Имунайн
  • Cyprus · Octanine
  • Czechia · Immunine, Octanine F
  • Germany · Alphanine, Haemonine
  • 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 FAMHP / AFMPS (Belgium). 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/9042aa7b-87b4-4fba-b45e-f541d2407a64
GET /v1/drugs/9042aa7b-87b4-4fba-b45e-f541d2407a64?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.

{
  "form": "Powder and solvent for solution for injection",
  "source": "afmps",
  "status": "REVOKED",
  "name_en": "PPSB Solvent Detergent Rode Kruis",
  "name_fr": "PPSB Solvent Detergent Rode Kruis",
  "name_nl": "PPSB Solvent Detergent Rode Kruis",
  "amp_code": "SAM188431-00",
  "strengths": [
    "400.0000",
    "300.0000",
    "300.0000",
    "100.0000"
  ],
  "pack_count": 1,
  "substances": [
    "Human Coagulation Factor IX",
    "Human Coagulation Factor II",
    "Human coagulation factor X",
    "Human Coagulation Factor VII"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Coagulation Factor IX, II, VII and X in Combination",
  "authorisation_numbers": [
    "BE188431"
  ]
}

See everything about coagulation factor ix, ii, vii and x in combination.

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.