Spain· ES:02220002
TRACLEER 62,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
A medicinal product containing bosentán, registered in Spain by Janssen-Cilag International N.V.
Checked against AEMPS CIMA (Spain) on
Informational only — not a medical device.
The record
At a glance
AEMPS CIMA (Spain)- Active substance
- bosentán
- Manufacturer
- Janssen-Cilag International N.V
- Country
- Spain (ES)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- AEMPS CIMA (Spain)
- Last checked
- September 12, 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.
Same medicine, other countries
Bosentán in 16 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaBOSENTAN ABDIAbdi Farma GmbH, Heppenheim
- FinlandBosentan AccordAccord Healthcare B.V.
- BelgiumBosentan AB 62.5 mgAurobindo
- NetherlandsBosentan ABDI 62,5 mg, filmomhulde tablettenAbdi Farma GmbH
- SwedenBosentan Accord 62,5 mg Filmdragerad tablettAccord Healthcare B.V.
- ItalyBOSENTAN ABDIABDI FARMA GMBH
- IrelandBosentan Accord 62.5 mg film-coated tabletsAccord Healthcare Ireland Ltd.
- FranceBOSENTAN ACCORD 62,5 mg, comprimé pelliculéACCORD HEALTHCARE FRANCE
Authorised across Europe · EMA
The same active substance is authorised in 29 EEA countries. Names it is sold under:
- Austria · Bosentan Accord, Bosentan Reddy
- Belgium · Bosentan Accord, Bosentan Sandoz
- 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
- 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 AEMPS CIMA (Spain). 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/ed318ce7-ba60-4799-a065-54bfdf20bd89 GET /v1/drugs/ed318ce7-ba60-4799-a065-54bfdf20bd89?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.
{
"cpresc": "Uso Hospitalario",
"estado": "{\"aut\":1023660000000}",
"nregistro": "02220002",
"substance": "bosentán"
}See everything about bosentán.
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.