Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Tracleer 62.5 mg film-coated tablets.
Tracleer 125 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablets). Tracleer 62.5 mg film-coated tablets: Orange-white, round, biconvex, film-coated tablets, embossed with “62,5” on one side. Tracleer 125 mg film-coated tablets: Orange-white, oval, biconvex, film-coated tablets, embossed with “125” on one side. |
Tracleer 62.5 mg film-coated tablets: Each film-coated tablet contains 62.5 mg bosentan (as monohydrate).
Tracleer 125 mg film-coated tablets: Each film-coated tablet contains 125 mg bosentan (as monohydrate).
Excipient with known effect:
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Bosentan is a dual endothelin receptor antagonist (ERA) with affinity for both endothelin A and B (ETA and ETB) receptors. Bosentan decreases both pulmonary and systemic vascular resistance resulting in increased cardiac output without increasing heart rate. |
| List of Excipients |
|---|
|
Tablet core: Maize starch Film coat: Hypromellose |
Tracleer 62.5 mg film-coated tablets:
PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. Cartons contain 14, 56 or 112 film-coated tablets.
White high-density polyethylene bottles with a silica gel desiccant containing 56 film-coated tablets. Cartons contain 56 film-coated tablets.
Tracleer 125 mg film-coated tablets:
PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. Cartons contain 56 or 112 film-coated tablets.
White high-density polyethylene bottles with a silica gel desiccant containing 56 film-coated tablets. Cartons contain 56 film-coated tablets.
Not all pack sizes may be marketed.
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340, Beerse, Belgium
Tracleer 62.5 mg film-coated tablets:
EU/1/02/220/001
EU/1/02/220/002
EU/1/02/220/003
EU/1/02/220/007
Tracleer 125 mg film-coated tablets:
EU/1/02/220/004
EU/1/02/220/005
EU/1/02/220/008
Date of first authorisation: 15 May 2002
Date of latest renewal: 20 April 2012
| Drug | Countries | |
|---|---|---|
| TRACLEER | Austria, Australia, Canada, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States |
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