Belgium· BE-AMP-SAM246601-00

Tracleer 125 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 September 26, 2026

Informational only — not a medical device.

Compare price across countriesPer daily dose · free account Ask the assistant about bosentan monohydrateAnswers with sources · free account Check 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 account Drug 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
0775833
be_apb
2071231

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 medicines How 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.

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/c7998f09-2762-410e-9030-723d9efbbd26
GET /v1/drugs/c7998f09-2762-410e-9030-723d9efbbd26?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 125 mg",
  "name_fr": "Tracleer 125 mg",
  "name_nl": "Tracleer 125 mg",
  "amp_code": "SAM246601-00",
  "strengths": [
    "125.0000",
    "125.0000"
  ],
  "pack_count": 3,
  "substances": [
    "Bosentan Monohydrate",
    "Bosentan",
    "Sodium Starch Glycolate"
  ],
  "medicine_type": "ALLOPATHIC",
  "atc_description": "Bosentan",
  "authorisation_numbers": [
    "EU/1/02/220/004",
    "EU/1/02/220/005",
    "EU/1/02/220/008"
  ]
}

API reference MCP server Plans

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.

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