FAVERIN Film-coated tablet Ref.[27715] Active ingredients: Fluvoxamine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Product name and form

Faverin 50 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Round, biconvex, scored, white to off-white film coated tablets imprinted ‘291’ on both sides of the score.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 50 mg fluvoxamine maleate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Fluvoxamine

The mechanism of action of fluvoxamine is thought to be related to selective serotonin re-uptake inhibition in brain neurones. There is minimum interference with noradrenergic processes. Receptor binding studies have demonstrated that fluvoxamine has negligible binding capacity to alpha adrenergic, beta adrenergic, histaminergic, muscarine cholinergic, dopaminergic or serotonergic receptors.

List of Excipients

Tablet cores:

Mannitol
Maize starch
Pregelatinised starch
Sodium stearyl fumarate
Colloidal anhydrous silica

Film-coat:

Hypromellose
Macrogol 6000
Talc
Titanium Dioxide E171

Pack sizes and marketing

PVC/PVdC/Aluminium press-through blister.

Pack sizes: 5, 10, 20, 30, 50, 60, 90, 100 and 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0034

Date of last renewal: 21/06/2009

Drugs

Drug Countries
FAVERIN Albania, Australia, Cyprus, Hong Kong, Ireland, Malta, Singapore, Turkey, United Kingdom, South Africa

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