Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
G & A Licensing Limited
250 Milligram
Tablets
2009-11-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1447/034/002 Case No: 2062487 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to G & A LICENSING LTD BALLYMURRAY, CO. ROSCOMMON, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product KLACID 250MG FILM-COATED TABLETS 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 13/11/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/11/2009_ _CRN 2062487_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klacid 250mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250mg of Clarithromycin For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablets _Product imported from _Italy A yellow ovaloid film-coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarithromycin is indicated for the treatment of infections due to susceptible organisms. Such infections include: 1. Lower respiratory tract infections (e.g. bronchitis, pneumonia). 2. Upper respiratory tract infections (e.g. pharyngitis, sinusitis). 3. Skin and soft tissue infections (e.g. folliculitis, cellulit Baca dokumen lengkapnya