BRIASETA Film-coated tablet Ref.[50436] Active ingredients: Ambrisentan

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland

Product name and form

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.

Qualitative and quantitative composition

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
Microcrystalline cellulose (E460(i))
Maize starch pregelatinised
Magnesium stearate (E470b)

Film-coat:

Polyvinyl alcohol (E1203)
Titanium dioxide (E171)
Macrogol (E1521)
Talc (E553b)
Red iron oxide (E172)

Pack sizes and marketing

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.

Marketing authorization holder

Rowex Ltd, Newtown, Bantry, Co. Cork, Ireland

Marketing authorization dates and numbers

PA0711/305/001

Date of first authorisation: 7th January 2022

Drugs

Drug Countries
BRIASETA Estonia, Ireland

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