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IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1046/001/003
Case No: 2074505
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
WINTHROP PHARMACEUTICALS UK LIMITED
ONE ONSLOW STREET, GUILDFORD, SURREY, GU1 4YS, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GABAPENTIN, 400 MILLIGRAM
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 05/01/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/01/2010_
_CRN 2074505_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gabapentin 400 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400mg hard capsule contains 400 mg of gabapentin
Excipients:
Each 400 mg hard capsule contains 63.966mg lactose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
Orange-yellow, hard capsules.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EPILEPSY
Gabapentin is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary
generalization in adults and children aged 6 years and above (see section 5.1).
_Gabapentin is indicated as monotherapy in the treatme
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