Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Winthrop Pharmaceuticals UK Limited
300 Milligram
Capsules Hard
2003-09-05
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1046/001/002 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, 300 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 300 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 300mg hard capsule contains 300mg of gabapentin. Excipients: Each 300mg hard capsule contains 47.974mg of lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (capsule) 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 treatment of Read the complete document