DEPAKINE CHRONO Prolonged-release tablet Ref.[51019] Active ingredients: Valproic acid

Source: Υπουργείο Υγείας (CY)  Revision Year: 2023  Publisher: Sanofi Winthrop Industrie, 82 avenue Raspail, 94250 Gentilly, France

Product name and form

Depakine Chrono 500 mg, prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablets.

Qualitative and quantitative composition

Sodium valproate 333 mg

Valproic acid 145 mg

Quantity corresponding to 500 mg sodium valproate per tablet.

For the 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

Ethylcellulose 20
Hypromellose 3000
Colloidal anhydrous silica
Colloidal hydrated silica
Saccharin sodium
Hypromellose 6
Macrogol 6000
30% polyacrylate (dispersion) (EUDRAGIT E 30D) expressed as dry extract
Talc
Titanium dioxide

Pack sizes and marketing

Bottle of 30 prolonged-release tablets.

Marketing authorization holder

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

Marketing authorization dates and numbers

19172

Date of first authorisation: 23 February 2001
Date of latest renewal: 5 January 2012

Drugs

Drug Countries
DEPAKINE-CHRONO Austria, Cyprus, Estonia, Spain, France, Croatia, Lithuania, Poland, Romania, Tunisia

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