In other countries
The same active substances on other registers, the same brand first.
- BosentacArgentina · 125 MG, 62,5 MG · comprimido recubierto · Oriental Farmaceutica I.C. e I.S.A.Same form
- PMS-BosentanCanada · 62.5 MG · Tablet · Pharmascience INCSame form
- PMS-BosentanCanada · 125 MG · Tablet · Pharmascience INCSame form
- Taro-BosentanCanada · 125 MG · Tablet · Taro Pharmaceuticals INCSame form
- Bosentan Accordpharma 125 MG Comprimidos Recubiertos con Pelicula EfgSpain · 125 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same form
- Bosentan Accordpharma 62,5 MG Comprimidos Recubiertos con Pelicula EfgSpain · 62,5 mg · comprimido recubierto con película · Accord Healthcare S.L.U.Same form
- Bosentan Aurovitas 125 MG Comprimidos Recubiertos con Pelicula EfgSpain · 129,082 mg · comprimido recubierto con película · Aurovitas Spain, S.A.U.Same 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 Zentiva 125 mg filmom obložene tableteCroatia · Filmom obložena tableta · Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, ČeškaSame form
- Bosentan ABDI 125 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Abdi Farma GmbHSame form
- Bosentan ABDI 62,5 mg, filmomhulde tablettenNetherlands · Filmomhulde tablet · Abdi Farma GmbHSame form
- Bosentan Accord 125 mg filmomhulde tablettenNetherlands · Filmomhulde tablet · Accord Healthcare B.V.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
- BOSENTOR 125 mg Film-Coated TabletSaudi Arabia · Pharmascience INC.Same form
- BOSENTOR 62.5 mg Film-Coated TabletSaudi Arabia · Pharmascience INC.Same 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
- BosentanUnited States · 32MG · tablet, for suspension · Natco Pharma LTDSame form
- TracleerUnited States · 125MG, 62.5MG · tablet · ActelionSame form
- bosentanaBrazil · Ranbaxy Farmacêutica LtdaSame substance
- bosentanaBrazil · Accord Farmacêutica LtdaSame substance
- bosentanaBrazil · Biolab Sanus Farmacêutica LtdaSame substance
- StayveerEuropean Union · Janssen-Cilag International NVSame substance
- TracleerEuropean Union · Janssen-Cilag International N.V.Same substance
- BOPAHO 125 mgRomania · 125mg · compr. film. · Zentiva, K.S.Same substance
- TRACLEER 125 mgRomania · 125mg · compr. film. · Janssen- Cilag International NVSame substance
- TRACLEER 125mgRomania · 125mg · compr. film. · Actelion Registration LTDSame substance
- TRACLEER Film Coated Tablets 125mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same substance
- Tracleer Film Coated Tablets 125MGTaiwan · 膜衣錠 · 嬌生股份有限公司Same substance
- TRACLEER Film Coated Tablets 62.5mgTaiwan · 膜衣錠 · 嬌生股份有限公司Same substance
Packs
| Pack | Code | Status |
|---|---|---|
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 14 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876011 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 28 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876023 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 30 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876035 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 50 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876047 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 56 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876050 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 60 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876062 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 90 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876074 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 98 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876086 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 112 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876098 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 30 COMPRESSE IN FLACONE HDPE | 044876100 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 100 COMPRESSE IN FLACONE HDPE | 044876112 | Autorizzata |
| 62,5 MG COMPRESSE RIVESTITE CON FILM- 1000 COMPRESSE IN FLACONE HDPE | 044876124 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 10 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876136 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 14 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876148 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 28 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876151 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 30 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876163 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 50 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876175 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 56 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876187 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 60 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876199 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 90 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876201 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 98 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876213 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 100 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876225 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 112 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876237 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 30 COMPRESSE IN FLACONE HDPE | 044876249 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 100 COMPRESSE IN FLACONE HDPE | 044876252 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 1000 COMPRESSE IN FLACONE HDPE | 044876264 | Autorizzata |
| 125 MG COMPRESSE RIVESTITE CON FILM- 120 COMPRESSE IN BLISTER PVC/PE/PVDC-AL | 044876276 | Autorizzata |
Documents
The official texts, at the regulator.
Sources and licences
Compiled by Prognia from the public register below; the register’s text is the official one.
Agenzia Italiana del Farmaco (AIFA), Italy
Agenzia Italiana del Farmaco (AIFA); https://drive.aifa.gov.it/farmaci/confezioni_fornitura.csv; HTTP Last-Modified Mon, 12 Oct 2026 23:02:44 GMT; acquired 2026-10-13T17:21:16.224007+00:00; native fields retained, source identifier and role projections are adaptations.
Licence: CC BY 4.0; AIFA published open-data catalog · Added 13 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
- Dosage form
- Compressa rivestita con film
- Register
- Italy (AIFA)
- Status
- Authorised
- Status in the register
- Autorizzata
- Registration
- AIC 044876
- Marketing authorisation holder
- Aurobindo Pharma (Italia) S.R.L.
- ATC code
- C02KX01
- Procedure
- Procedura Mutuo riconoscimento o Decentrata
- Supply
- Medicinali soggetti a prescrizione medica limitativa, vendibili al pubblico su prescrizione di centri ospedalieri o di specialisti