Source: Health Products Regulatory Authority (IE) Revision Year: 2022 Publisher: Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland
Briaseta 5 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Pink, circular film-coated tablet (6.5 mm in diameter) with “5” debossed on one side. |
Each film-coated tablet contains 5 mg of ambrisentan.
Excipient with known effect: Each film-coated tablet contains 91.7 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Ambrisentan |
Ambrisentan is an orally active, propanoic acid-class, ERA selective for the endothelin A (ETA) receptor. Endothelin plays a significant role in the pathophysiology of PAH. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Film-coat: Polyvinyl alcohol (E1203) |
PVC/PVdC//Aluminium or PVC/PE/PVdC//Aluminium blisters containing 10 or 30 film-coated tablets.
PVC/PVdC//Aluminium or PVC/PE/PVdC//Aluminium perforated unit dose blisters containing 10 × 1 or 30 × 1 film-coated tablets.
Not all pack sizes may be marketed.
Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland
PA0711/305/001
Date of first authorisation: 7th January 2022
| Drug | Countries | |
|---|---|---|
| BRIASETA | Estonia, Ireland |
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