SOLIAN Tablets Ref.[6169] Active ingredients: Amisulpride

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Product name and form

Solian 100 mg Tablets.

Pharmaceutical Form

Tablet.

White to off-white, round, flat-faced tablet engraved AMI 100 on one face and with a breakable bar on the other face.

Qualitative and quantitative composition

Each tablet contains 100 mg of the active substance, amisulpride.

Also contains 69.6 mg of lactose monohydrate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Amisulpride

Amisulpride is a neuroleptic. Amisulpride binds selectively with a high affinity to human dopaminergic D2/D3 receptor subtypes whereas it is devoid of affinity for D1, D4 and D5 receptor subtypes.

List of Excipients

Sodium starch glycolate
Lactose monohydrate
Microcrystalline cellulose
Hypromellose
Magnesium stearate

Pack sizes and marketing

PVC/aluminium foil blister packs containing 30, 60 or 90 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK

Marketing authorization dates and numbers

PL 04425/0651

Date of first authorisation: 6 July 1999
Date of latest renewal: 4 April 2007

Drugs

Drug Countries
SOLIAN Austria, Australia, Cyprus, Germany, Estonia, Spain, France, Hong Kong, Ireland, Italy, Lithuania, Mexico, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, South Africa

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