APROVEL Tablet Ref.[6932] Active ingredients: Irbesartan

Source: European Medicines Agency (EU)  Revision Year: 2023  Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France

Product name and form

Aprovel 75 mg tablets.

Pharmaceutical Form

Tablet.

White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

Qualitative and quantitative composition

Each tablet contains 75 mg of irbesartan.

Excipient with known effect: 15.37 mg of lactose monohydrate per tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Irbesartan

Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
List of Excipients

Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Magnesium stearate
Colloidal hydrated silica
Pregelatinised maize starch
Poloxamer 188

Pack sizes and marketing

Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 56 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Cartons of 56 × 1 tablet in PVC/PVDC/Aluminium perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France

Marketing authorization dates and numbers

EU/1/97/046/001-003
EU/1/97/046/010
EU/1/97/046/013

Date of first authorisation: 27 August 1997
Date of latest renewal: 27 August 2007

Drugs

Drug Countries
APROVEL Austria, Brazil, Cyprus, Germany, Ecuador, Estonia, Spain, France, Hong Kong, Ireland, Italy, Lithuania, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, United Kingdom, South Africa
 
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