Belgium· BE-AMP-SAM665058-00
Bosentan Accord 32 mg
A bosentan product containing bosentan monohydrate, registered in Belgium by Accord Healthcare. The same ATC class is registered in 18 of our 19 countries.
Checked against FAMHP / AFMPS (Belgium) on
Informational only — not a medical device.
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
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
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
Bosentan · price per daily dose (0.25 g)
USD · FX 28 Sept 2026
- CH Switzerland$66.51
- IT Italy$25.92
The record
At a glance
FAMHP / AFMPS (Belgium)- Active substance
- Bosentan Monohydrate
- Manufacturer
- Accord Healthcare
- 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 · 0
No packs listed by the register for this record.
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
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.
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.
- United StatesbosentanZydus Lifesciences Limited
- NetherlandsBosentan Accord 32 mg, dispergeerbare tablettenAccord Healthcare B.V.
- FinlandBosentan AccordAccord Healthcare B.V.
- SwedenBosentan Accord 32 mg Dispergerbar tablettAccord Healthcare B.V.
- PolandTracleerJanssen-Cilag International N.V.
- IrelandTracleer 32 mg dispersible tabletsJanssen-Cilag International NV
- SpainBOSENTAN ACCORDPHARMA 32 MG COMPRIMIDOS DISPERSABLES EFGAccord Healthcare S.L.U.
- FranceTRACLEER 32 mg, comprimé dispersibleJANSSEN CILAG INTERNATIONAL NV
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/84150b4d-d11b-45cc-bc91-2eeed2b79fb4 GET /v1/drugs/84150b4d-d11b-45cc-bc91-2eeed2b79fb4?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": "Dispersible tablet",
"source": "afmps",
"status": "AUTHORIZED",
"name_en": "Bosentan Accord 32 mg",
"name_fr": "Bosentan Accord 32 mg",
"name_nl": "Bosentan Accord 32 mg",
"amp_code": "SAM665058-00",
"strengths": [
"33.0450",
"33.0450",
"32.0000",
"32.0000",
"1.8000",
"3.7000"
],
"pack_count": 2,
"substances": [
"Bosentan Monohydrate",
"Bosentan",
"Acesulfame Potassium",
"Aspartame"
],
"medicine_type": "ALLOPATHIC",
"atc_description": "Bosentan",
"authorisation_numbers": [
"BE665058"
]
}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.