국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
GABAPENTIN
Milpharm Limited
400 Milligram
Capsule
2003-11-18
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1050/001/003 Case No: 2062962 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MILPHARM LIMITED ARES, ODYSSEY BUSINESS PARK, WEST END ROAD, SOUTH RUISLIP HA4 6QD, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product GABTURE 400 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 12/03/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/03/2009_ _CRN 2062962_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gabture 400 mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gabapentin 400mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Size '0' orange/orange hard gelatin capsule marked 'MG 400'. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Monotherapy in adults and children over 12 years of age_ Gabapentin is used as an antiepileptic indicated for monotherapy or add-on treatment for adults and children over 12 years of age with partial seizures or partial seizures with secondary generalisation, including patients with newly diagnosed seizures. Monotherapy in child 전체 문서 읽기