EPI-CHRONO 300 MG PROLONGED-RELEASE TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-04-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
VALPROATE SODIUM VALPROIC ACID
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
300 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Authorization date:
2007-12-07
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0540/149/002
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 300 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 300 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Epichrono 300mg prolonged-release tablet contains 199.8 mg sodium valproate and 87.0 mg valproic acid,
equivalent to 300 mg sodium valproate.
This product contains 27.6mg 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 that
Read the complete document
