Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Or trading as: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom
Epilim 400 mg Powder and Solvent for solution for injection/infusion.
| Pharmaceutical Form |
|---|
|
Powder and Solvent for solution for injection/infusion. The powder is hygroscopic, white or practically white crystalline. The solvent is a clear, colourless solution. |
Each vial of freeze-dried powder contains 400 mg of the active substance Sodium Valproate.
Each ampoule of solvent contains 4 ml of Water for Injection.
For 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 |
|---|
|
Powder: None Solvent: None |
Colourless, Type I glass vial flat base for lyophilisation. Closed by a slotted, chlorobutyl rubber stopper, secured by an aluminium collar and a plastic flip-off cap. The vial is supplied packed in a cardboard carton along with one colourless Type I glass, bottle-shaped ampoule containing 4 ml of solvent (Water for Injection).
Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom
Or trading as: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom
PL 04425/0685
Date of First Authorisation: 18 August 1993
Date of Latest Renewal: 28 May 2004
| Drug | Countries | |
|---|---|---|
| EPILIM | Australia, Hong Kong, Ireland, Malta, Nigeria, New Zealand, Singapore, United Kingdom, South Africa |
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