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Belgium· BE-AMP-SAM246574-00

Tracleer 62.5 mg

A bosentan product containing bosentan monohydrate, registered in Belgium by Janssen-Cilag International. The same ATC class is registered in 18 of our 19 countries.

ATC C02KX01

Checked against FAMHP / AFMPS (Belgium) on

Informational only — not a medical device.

SOURCE REGISTER · BEFAMHP / AFMPS (Belgium)normalisedTracleer 62.5 mgATCC02KX01REGISTER NO.BE-AMP-SAM246574-00PACKS LISTED2CHECKEDSeptember 26, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about bosentan monohydrateAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

Where it is registered

Bosentan is registered in 18 of 19 countries.

Countries holding a registration under ATC C02KX01 (bosentan), each read from that country’s own register.

  • This record: Belgium, from FAMHP / AFMPS (Belgium)
  • 11 of them publish a price we can compare per daily dose
Search bosentan products by name

Bosentan · ATC C02KX01

18 / 19 countries

  • Belgiumprice
  • Canada
  • Czechiaprice
  • Denmark
  • Finlandprice
  • Franceprice
  • Germany
  • Icelandprice
  • Ireland
  • Italyprice
  • Netherlands
  • Norwayprice
  • Polandprice
  • Spainprice
  • Sweden
  • 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.

Price per daily dose

What a daily dose of bosentan costs, country by country.

Normalised to the WHO defined daily dose (0.25 g), the median price runs from $25.92 in Italy to $66.51 in Switzerland — a ×2.6 gap.

  • 2 markets with a comparable price for this class
  • Public list prices, converted to USD at the rate date shown
Open the full comparison — free accountDrug prices for market access

Bosentan · price per daily dose (0.25 g)

USD · FX 28 Sept 2026

  • CH Switzerland$66.51
  • IT Italy$25.92
Median listed price per WHO defined daily dose, in each market that publishes a price. Open the full comparison

The record

At a glance

FAMHP / AFMPS (Belgium)
Active substance
Bosentan Monohydrate
Manufacturer
Janssen-Cilag International
Country
Belgium (BE)
ATC code
C02KX01
ATC class
Bosentan
Defined daily dose
0.25 g, O
Reimbursed
Not published by this register
Source register
FAMHP / AFMPS (Belgium)
Last checked
September 26, 2026

Packs & prices · 2

  • be_apb
    0775825
  • be_apb
    2071223

Regulatory notes

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

Interactions

355 interactions on record for bosentan.

Graded by severity as the source publishes them — 45 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
Check bosentan against other medicinesHow interaction checks work

Bosentan · interactions on record

355 records

  • 45 severe
  • 227 moderate
  • 7 minor
  • 69 info

Most severe, free to view

  • GlibenclamideA10BB01severe
  • Levonorgestrel and ethinylestradiolG03AA07severe
  • Desogestrel and ethinylestradiolG03AA09severe
  • Drospirenone and ethinylestradiolG03AA12severe

7 more interactions with mechanism and management, from a commercially licensed source.

Sign in to check
  • 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

Bosentan in 16 other countries

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

All bosentan products

Authorised across Europe · EMA

The same active substance is authorised in 29 EEA countries. Names it is sold under:

  • Austria · Bosentan Accord, Bosentan Reddy
  • Bulgaria · Bosentan Sdz, Бозентан Акорд
  • Cyprus · Bactoced, Bosentan Accord
  • Czechia · Bosentan Abdi, Bosentan Accord
  • Germany · Bosentan 1 A Pharma, Bosentan Accord
  • Denmark · Bosentan Accord, Bosentan Cipla
  • Estonia · Bosentan Accord, Bosentan Norameda
  • Spain · Bosentan Accordpharma, Bosentán Accordpharma
  • Finland · Bosentan Accord
  • France · Bosentan Accord, Bosentan Arrow
  • United Kingdom (Northern Ireland) · Bosentan Accord, Bosentan Generics [uk]
  • Greece · Bocleer, Klimurtan
  • Croatia · Bosentan Cipla, Bosentan Makpharm
  • Hungary · Bosentan Pharmascience
  • Ireland · Bosentan Accord, Bosentan Zentiva
  • Iceland · Stayveer, Tracleer
  • Italy · Bosentan Abdi, Bosentan Accord
  • Liechtenstein · Stayveer, Tracleer
  • Lithuania · Bosentan Accord, Bosentan Norameda
  • Latvia · Bosentan Accord, Bosentan Norameda
  • Malta · Bosentan Aurobindo
  • Netherlands · Bosentan Abdi, Bosentan Accord
  • Norway · Bosentan Accord, Bosentan Cipla
  • Poland · Bopaho, Bosentan Accord
  • Portugal · Bosentano Accord, Bosentano Aurobindo
  • Romania · Bopaho, Bosentan Accord
  • Sweden · Bosentan Accord, Bosentan Sandoz
  • Slovenia · Bosentan Norameda
  • Slovakia · Bosentan Accord

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/e9531d76-79dc-49a2-b1e1-c21641df83a2
GET /v1/drugs/e9531d76-79dc-49a2-b1e1-c21641df83a2?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": "Film-coated tablet",
  "source": "afmps",
  "status": "AUTHORIZED",
  "name_en": "Tracleer 62.5 mg",
  "name_fr": "Tracleer 62.5 mg",
  "name_nl": "Tracleer 62.5 mg",
  "amp_code": "SAM246574-00",
  "strengths": [
    "62.5000",
    "62.5000"
  ],
  "pack_count": 4,
  "substances": [
    "Bosentan Monohydrate",
    "Bosentan",
    "Sodium Starch Glycolate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Bosentan",
  "authorisation_numbers": [
    "EU/1/02/220/001",
    "EU/1/02/220/002",
    "EU/1/02/220/003",
    "EU/1/02/220/007"
  ]
}
API referenceMCP serverPlans

See everything about bosentan.

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.

Try it freeOpen in the console