EPIVAL Prolonged-release tablet Ref.[50749] Active ingredients: Valproic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: G.L. Pharma GmbH, Schlossplatz 1, A-8502 Lannach, Austria

Product name and form

Epival CR 300 mg prolonged-release tablets.

Pharmaceutical Form
Prolonged-release tablet. White, oval-shaped prolonged-release tablet with a score line and engraving “CC3” on one side. The tablet can be divided into equal doses. Epival CR 300 mg prolonged-release tablets are used in adults, children and adolescents.

Qualitative and quantitative composition

Each tablet contains 300 mg sodium valproate.

Excipient with known effect: This medicine contains 42 mg sodium in each prolonged-release 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
Tablet core: Citric acid monohydrate Ethylcellulose Ammonio methacrylate copolymer (type B) (contains sorbic acid) Purified talc Colloidal hydrated silica Magnesium stearate Film-coating material: Ammonio methacrylate copolymer (type A & B) (contains sorbic acid) Purified talc Carmellose sodium Titanium dioxide (E171) Triethyl citrate Vanillin

Pack sizes and marketing

a) Amber glass tablet container (hydrolytic resistance type III, Ph.Eur.) with HDPE tamper-resistant white screw-cap, and HDPE white tear-band lid further packed into a cardboard carton.

Or alternatively

b) HDPE cylindrical tablet container with LDPE tamper-resistant snap-on cap with LDPE tear-band lid and LDPE sealing ring further packed into a cardboard carton

Pack sizes: 30, 50, 100 tablets.

Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, A-8502 Lannach, Austria

Marketing authorization dates and numbers

PL 21597 / 0005

Date of first authorisation: June 13^th, 2001 (UK)
Date of last renewal: April 17^th, 2006

Drugs

Drug	Countries
EPIVAL	Canada, Mexico, United Kingdom

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.