Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Lexon (UK) Ltd
100 Milligram
Capsule
2005-06-10
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA1097/001/001 Case No: 2027938 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to LEXON (UK) LTD UNIT 18, OXLEASOW ROAD, EAST MOONS MOAT, WORCESTERSHIRE B98 0RE, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product GABAPENTIN 100 MG 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 31/10/2006 until 09/06/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/11/2006_ _CRN 2027938_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabapentin 100 mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg hard capsule contains 100 mg of gabapentin. Excipients: Each 100 mg hard capsule contains 13 mg lactose (as monohydrate). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard A white opaque hard gelatin capsule. 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 monotherap Belgenin tamamını okuyun