EPILIM CHRONOSPHERE 50MG PROLONGED-RELEASE GRANULE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
VALPROATE SODIUM VALPROIC ACID
Available from:
Sanofi-Aventis Ireland Limited
Dosage:
50 Milligram
Pharmaceutical form:
Granules Prolonged Release
Authorization date:
2007-03-02
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0540/150/004
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
EPILIM CHRONOSPHERE 50MG PROLONGED-RELEASE GRANULES
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 01/03/2012.
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
Epilim Chronosphere 50mg prolonged-release granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet of prolonged-release granules contains:
Sodium valproate
33.33 mg
Valproic acid
14.51 mg
Equivalent to 50 mg sodium valproate.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release granules.
Sachets containing small, off-white to slightly yellow, waxy microgranules
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of generalised, partial or other epilepsy.
Treatment and prevention of mania associated with bipolar disorders.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Chronosphere i
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