EPILIM CHRONOSPHERE Modified release granules Ref.[7380] Active ingredients: Valproic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Aventis Pharma Limited, One Onslow StreetGuildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Product name and form

Epilim Chronosphere MR 50 mg modified release granules.

Pharmaceutical Form

Modified release granules.

Sachets containing small, off-white to slightly yellow, waxy microgranules.

Qualitative and quantitative composition

Each sachet of 152 mg modified-release granules contains:

Sodium valproate 33.33 mg.

Valproic acid 14.51 mg.

Equivalent to 50 mg sodium valproate.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Valproic acid

Valproic acid is anti-convulsant. The most likely mode of action for valproate is potentiation of the inhibitory action of gamma amino butyric acid (GABA) through an action on the further synthesis or further metabolism of GABA.

List of Excipients

Paraffin hard, glycerol dibehenate, silica colloidal hydrated.

Pack sizes and marketing

Epilim Chronosphere MR 50 mg modified release granules are filled into sachets of a paper/aluminium/ionomer resin complex.

Epilim Chronosphere sachets are available in cartons of 30 and 50 sachets.

Marketing authorization holder

Aventis Pharma Limited, One Onslow StreetGuildford, Surrey, GU1 4YS, UK

or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Marketing authorization dates and numbers

PL 04425/0310

Date of first authorisation: 11 July 2006

Drugs

Drug Countries
EPILIM CHRONO Hong Kong, Ireland, Malta, Singapore, United Kingdom

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