Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Masterfarm SL
400mg Milligram
Capsules Hard
2004-05-21
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1146/001/003 Case No: 2058882 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MASTERFARM SL C/BLANQUERS 85, 17820 BANYOLES, GIRONA, SPAIN an authorisation, subject to the provisions of the said Regulations, in respect of the product GABAPENTIN MASTERFARM 400MG CAPSULES 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 21/05/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/01/2010_ _CRN 2058882_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin Masterfarm 400 mg Capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gabapentin Masterfarm 400 mg capsules contains 400mg of gabapentin per capsule. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. White hard gelatin capsule, containing white powder. 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 with and withou Read the complete document