VALPROAT 300 Milligram Prolonged Release Capsules
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
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Active ingredient:
VALPROATE SODIUM VALPROIC ACID
Available from:
Rowex Ltd
INN (International Name):
VALPROATE SODIUM VALPROIC ACID
Dosage:
300 Milligram
Pharmaceutical form:
Prolonged Release Capsules
Authorization status:
Withdrawn
Authorization date:
2008-09-10
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA0711/099/001
Case No: 2049598
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
ROWEX LTD
BANTRY, CO. CORK, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
VALPROAT 300 MG PROLONGED-RELEASE TABLETS
The particulars of which are set out in Part I and Part II of 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 25/06/2008 until 27/07/2011.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/06/2008_
_CRN 2049598_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valproat 300 mg Prolonged-Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged-release tablet contains 200 mg sodium valproate and 87 mg valproic acid, together equivalent to 300
mg sodium valproate
Excipients: 28 mg sodium
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release tablet:
White, oblong prolonged-release tablet, with a score line
The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary form of generalized epilepsy
-
typical and atypical absences (petit mal)
-
myoclonic seizures
-
tonic-clonic seizures (grand mal)
-
mixed forms of
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