Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Winthrop Arzneimittel GmbH
600 Milligram
Coated Tablets
2006-03-10
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA1300/001/001 Case No: 2036728 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to WINTHROP ARZNEIMITTEL GMBH INDUSTRIESTRASSE 26, 56218 MULHEIM-KARLICH, GERMANY an authorisation, subject to the provisions of the said Regulations, in respect of the product GABAPENTIN 600 MG FILM COATED TABLETS 600 MILLIGRAM COATED 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 09/05/2007 until . Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/05/2007_ _CRN 2036728_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin 600 mg Film Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 600 mg film-coated tablet contains 600 mg of gabapentin. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet White, biconvex oval shaped, film coated tablet. 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 partial seizures Read the complete document