Belgium· BE-AMP-SAM185595-00

Flolan 0.5 mg

A epoprostenol product containing epoprostenol sodium, registered in Belgium by GlaxoSmithKline Pharmaceuticals. The same ATC class is registered in 14 of our 19 countries.

ATC B01AC09

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedFlolan 0.5 mgATCB01AC09REGISTER NO.BE-AMP-SAM185595-00PACKS LISTED2CHECKEDSeptember 26, 2026

Where it is registered

Epoprostenol is registered in 14 of 19 countries.

Countries holding a registration under ATC B01AC09 (epoprostenol), 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

Epoprostenol · ATC B01AC09

14 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Franceprice
  • Germany
  • Ireland
  • Japan
  • Netherlands
  • Norwayprice
  • Polandprice
  • Switzerlandprice
  • United Kingdom
  • United Statesprice
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
Epoprostenol Sodium
Manufacturer
GlaxoSmithKline Pharmaceuticals
Country
Belgium (BE)
ATC code
B01AC09
ATC class
Epoprostenol
Defined daily dose
38 mcg, P
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    7717895
  • be_apb
    3465713

Regulatory notes

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

Interactions

402 interactions on record for epoprostenol.

Graded by severity as the source publishes them — 34 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

Epoprostenol · interactions on record

402 records

  • 34 severe
  • 269 moderate
  • 4 minor
  • 95 info

Most severe, free to view

  • DalteparinB01AB04severe
  • EnoxaparinB01AB05severe
  • DanaparoidB01AB09severe
  • TinzaparinB01AB10severe
  • 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

Epoprostenol in 12 other countries

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

All epoprostenol products

Authorised across Europe · EMA

The same active substance is authorised in 16 EEA countries. Names it is sold under:

  • Austria · Flolan
  • Czechia · Flolan, Veletri
  • Germany · Veletri
  • Denmark · Flolan
  • Spain · Epoprostenol Normon, Epoprostenol Sun
  • France · Epoprostenol Panpharma, Veletri
  • United Kingdom (Northern Ireland) · Epoprostenol Mercury Pharmaceuticals Ltd, Epoprostenol Sodium Hexal
  • Greece · Veletri
  • Hungary · Veletri
  • Ireland · Flolan, Veletri
  • Italy · Caripul, Flolan
  • Luxembourg · Flolan, Veletri
  • Netherlands · Epoprostenol Sun, Epoprostenol Sun Pharmaceutical Industries Europe
  • Poland · Veletri
  • Portugal · Epoprostenol Normon, Veletri
  • Slovakia · Veletri

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/b7eda59a-a6d6-42b5-adbc-90a5c83219e5
GET /v1/drugs/b7eda59a-a6d6-42b5-adbc-90a5c83219e5?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 infusion",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Flolan 0.5 mg",
  "name_fr": "Flolan 0.5 mg",
  "name_nl": "Flolan 0.5 mg",
  "amp_code": "SAM185595-00",
  "strengths": [
    "0.5000",
    "50.0000",
    "2.9320",
    "73.3000"
  ],
  "pack_count": 1,
  "substances": [
    "Epoprostenol Sodium",
    "Epoprostenol",
    "Mannitol",
    "Sodium Chloride",
    "Sodium Hydroxide"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Epoprostenol",
  "authorisation_numbers": [
    "BE185595"
  ]
}

See everything about epoprostenol.

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.