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Medicines
Spain
Bosentan

AEMPS 2002

Bosentan

TRACLEER 125 mg COMPRIMIDOS RECUBIERTOS CON PELICULA

125 mg comprimido recubierto con películaSpainAuthorisedAuthorised 9 Jun 2002

Product informationAsk Osler about it

On this page

In other countries
Packs
Documents
Sources and licences

In other countries

The same active substances on other registers, the same brand first.

TracleerBrazil · Actelion Pharmaceuticals do Brasil LtdaSame brand
TracleerCanada · 62.5 MG · Tablet · Janssen INCSame brand
TracleerCanada · 125 MG · Tablet · Janssen INCSame brand
TracleerEuropean Union · Janssen-Cilag International N.V.Same brand
TracleerCroatiaSame brand
TracleerItaly · Compressa rivestita con film · Janssen-Cilag International N.V.Same brand
Tracleer 125 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand

More with the same substance on this register

Bosentan Accordpharma 125 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 125 mg · comprimido recubierto con películaSpain
Bosentan Accordpharma 62,5 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 62,5 mg · comprimido recubierto con película

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

Tracleer 32 mg, dispergeerbare tablettenNetherlands · Dispergeerbare tablet · Janssen-Cilag International NV

Same brand

🇳🇱Tracleer 62,5 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Janssen-Cilag International NVSame brand

🇷🇴TRACLEER 125 mgRomania · 125mg · compr. film. · Janssen- Cilag International NVSame brand

🇷🇴TRACLEER 125mgRomania · 125mg · compr. film. · Actelion Registration LTDSame brand

🇸🇦Tracleer 125 MG Film Coated TabletSaudi Arabia · Haupt Pharma Wulfing GmbHSame brand

🇸🇦Tracleer 62.5 MG Film Coated TabletSaudi Arabia · Haupt Pharma Wulfing GmbHSame brand

🇹🇼TRACLEER Film Coated Tablets 125mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇹🇼Tracleer Film Coated Tablets 125MGTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇹🇼Tracleer Film Coated Tablets 62.5MGTaiwan · 膜衣錠 · 嬌生股份有限公司Same brand

🇺🇸TracleerUnited States · 32MG · tablet, for suspension · ActelionSame brand

🇺🇸TracleerUnited States · 125MG, 62.5MG · tablet · ActelionSame brand

🇦🇷BosentacArgentina · 125 MG, 62,5 MG · comprimido recubierto · Oriental Farmaceutica I.C. e I.S.A.Same form

🇨🇦PMS-BosentanCanada · 125 MG · Tablet · Pharmascience INCSame form

🇭🇷Bosentan Makpharm 125 mg filmom obložene tableteCroatia · filmom obložena tableta · Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, HrvatskaSame form

🇭🇷Bosentan Makpharm 62,5 mg filmom obložene tableteCroatia · filmom obložena tableta · Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, HrvatskaSame form

🇮🇹Bosentan AbdiItaly · Compressa rivestita con film · Abdi Farma GmbHSame form

🇮🇹Bosentan AccordItaly · Compressa rivestita con film · Accord Healthcare, S.L.U.Same form

🇳🇿Bosentan Dr Reddy'sNew Zealand · Tab 125 mgSame form

🇳🇿Bosentan Dr Reddy'sNew Zealand · Tab 62.5 mgSame form

🇷🇸Bosentan PharmascienceSerbia · 125mg · film tableta · Evropa Lek Pharma D.O.O. BeogradSame form

🇷🇸Bosentan PharmascienceSerbia · 62.5mg · film tableta · Evropa Lek Pharma D.O.O. BeogradSame form

🇷🇸Bosentan PharmascienceSerbia · 62.5mg · film tableta · Evropa Lek Pharma D.O.O. BeogradSame form

🇸🇦BOSENTOR 125 mg Film-Coated TabletSaudi Arabia · Genvion CorporationSame form

🇸🇬Proart Film Coated Tablets 125MGSingapore · 125.00mg · tablet, film coated · Ranbaxy (Malaysia) SDN. BHD.Same form

🇸🇬Proart Film Coated Tablets 62.5MGSingapore · 62.50mg · tablet, film coated · Ranbaxy (Malaysia) SDN. BHD.Same form

🇺🇸BosentanUnited States · 125MG, 62.5MG · tablet · MylanSame form

🇧🇷bosentanaBrazil · Biolab Sanus Farmacêutica LtdaSame substance

🇧🇷bosentanaBrazil · Accord Farmacêutica LtdaSame substance

🇪🇺StayveerEuropean Union · Janssen-Cilag International NVSame substance

🇷🇴BOPAHO 125 mgRomania · 125mg · compr. film. · Zentiva, K.S.Same substance

Packs

Pack	Code	Status
TRACLEER 125 mg COMPRIMIDOS RECUBIERTOS CON PELICULA, 56 comprimidos	759936

Documents

The official texts, at the regulator.

Summary of product characteristicsAEMPS
Package leafletAEMPS
Register entryAEMPS

Sources and licences

Compiled by Prognia from the public register below; the register’s text is the official one.

Agencia Española de Medicamentos y Productos Sanitarios

Fuente de la información: Agencia Española de Medicamentos y Productos Sanitarios www.aemps.gob.es; CIMA medicamentos, acquired 11 October 2026 UTC; each source response/update date retained.

Licence: AEMPS explicit public open-data reuse for citizens and companies; source attribution and update date required · Added 12 Oct 2026

Report an error or request removalCorrections from the holder or the register are welcome.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Active substance: Bosentan
Strength: 125 mg
Dosage form: comprimido recubierto con película
Route: vía oral
Register: Spain (AEMPS)
Status: Authorised
Status in the register: Autorizado, no comercializado
Authorised: 9 Jun 2002
Registration: 02220004
Marketing authorisation holder: Janssen-Cilag International N.V
Procedure: EU centralised
Supply: Uso Hospitalario

🇪🇸Spain

AEMPSBosentan Aurovitas 125 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 129,082 mg · comprimido recubierto con película🇪🇸Spain

AEMPSBosentan Aurovitas 62,5 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 64,541 mg · comprimido recubierto con película🇪🇸Spain

AEMPSBosentan Cipla 125 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 129,080 mg · comprimido recubierto con película🇪🇸Spain

AEMPSBosentan Cipla 62,5 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 64,540 mg · comprimido recubierto con película🇪🇸Spain

AEMPSBosentan Kern Pharma 125 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 129,082 mg · comprimido recubierto con película🇪🇸Spain

AEMPSBosentan Kern Pharma 62,5 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 64,541 mg · comprimido recubierto con película🇪🇸Spain

AEMPSBosentan Normon 125 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 129,1 mg · comprimido recubierto con película🇪🇸Spain

AEMPSBosentan Normon 62,5 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 64,55 mg · comprimido recubierto con película🇪🇸Spain

AEMPSBosentan Sandoz Farmaceutica 125 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 129,082 mg · comprimido recubierto con película🇪🇸Spain

AEMPSBosentan Sun 125 MG Comprimidos Recubiertos con Pelicula EfgBosentan · 129,083 mg · comprimido recubierto con película🇪🇸Spain