SABRIL Film-coated tablet Ref.[9296] Active ingredients: Vigabatrin

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 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

Sabril 500 mg film-coated tablets.

Pharmaceutical Form
Film-coated tablet. White to off-white, oval, biconvex, tablets with a break-line on one side and “Sabril” engraved on the other side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 500mg vigabatrin.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Vigabatrin	Vigabatrin is a selective irreversible inhibitor of GABA transaminase, the enzyme responsible for the breakdown of GABA (gamma aminobutyric acid). Vigabatrin increases the concentration of GABA, the major inhibitory neurotransmitter in the brain.

List of Excipients
Tablet core: Povidone K30 (E1201) Microcrystalline cellulose (E460) Magnesium stearate Sodium starch glycollate (Type A) Tablet coating: Hypromellose 15 mPa.s (E464) Titanium dioxide (E171) Macrogol 8000

Pack sizes and marketing

Clear colourless PVC-aluminium blisters of 10 film-coated tablets or

Opaque blue PVC-aluminium blisters of 10 film-coated tablets.

Each blister pack contains 30, 50, 60, 100 or 200 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 04425/0171

26^th January 2001/19^th June 2006

Drugs

Drug	Countries
SABRIL	Austria, Australia, Brazil, Canada, Estonia, France, Hong Kong, Ireland, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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