Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
VALPROATE SODIUM VALPROIC ACID
Sanofi-Aventis Ireland Limited
500 Milligram
Prolonged Release Capsules
2007-12-07
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0540/149/003 Case No: 2081454 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to SANOFI-AVENTIS IRELAND LIMITED CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product EPI-CHRONO 500 MG PROLONGED-RELEASE TABLETS the particulars of which are set out in the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 13/07/2010 until 23/08/2012. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/07/2010_ _CRN 2081454_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Epi-Chrono 500 mg Prolonged-Release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Epichrono 500 mg prolonged-release tablet contains 333 mg sodium valproate and 145 mg valproic acid, equivalent to 500 mg sodium valproate. This product contains 46.08 mg of sodium. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. Violet, oblong, biconvex, film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of generalised, partial or other epilepsy. In certain cases EpiChrono may be an appropriate choice for women of childbearing potential, provided th Read the complete document