国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
AZITHROMYCIN DIHYDRATE
Pfizer Limited
500mg Milligram
Film Coated Tablet
1996-05-08
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0019/047/009 Case No: 2075523 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to PFIZER LIMITED RAMSGATE ROAD, SANDWICH, KENT CT13 9NJ, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product ZITHROMAX 500 MG TABLETS 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 07/07/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/07/2010_ _CRN 2075523_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zithromax 500 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: azithromycin. The tablets contain azithromycin dihydrate equivalent to 500mg azithromycin. Also contains up to 36 mg lactose anhydrous. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated Tablet White, capsule shaped, film-coated tablets engraved “ZTM 500”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Azithromycin is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms (see section 5.1 Pharmacodynamic properties): o bronchitis o community-acquired pneumonia o sinusiti 完全なドキュメントを読む