国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
CEFALEXIN
Actavis Group PTC ehf
500 Milligram
Capsules Hard
2009-04-03
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA1380/041/002 Case No: 2084272 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ACTAVIS GROUP PTC EHF REYKJAVIKURVEGI 76-78, 220 HAFNARFJORDUR, ICELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CEFALEXIN 500MG HARD CAPSULES the particulars of which are set out in 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 19/08/2010 until 02/04/2014. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/08/2010_ _CRN 2084272_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cefalexin 500mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains, as active ingredient, cefalexin monohydrate equivalent to 500 mg of cefalexin base. Excipients: Brilliant blue (E133) and sunset yellow (E110). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Green coloured opaque cap and light green coloured opaque body size “0” hard gelatin capsules imprinted with black “CEF” on cap and “500” on body, filled with white to off white granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cefalexin is a semi-synthetic cephalosporin antibiotic for oral 完全なドキュメントを読む