Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
B & S Healthcare
CLARITHROMYCIN
500 Milligram
Modified-release Tablets
Withdrawn
0000-00-00
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PPA1328/014/001 Case No: 2077020 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product KLACID LA 500MG MODIFIED RELEASE 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 18/06/2010 until 19/10/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/06/2010_ _CRN 2077020_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Klacid LA 500mg Modified release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg clarithromycin Excipients: Lactose For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Modified release tablet. _Product imported from Italy:_ Yellow, oval tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Klacid LA is indicated for treatment of infections caused by susceptible organisms. Indications include: Lower respiratory tract infections for example bronchitis and pneumonia. Upper respiratory tract infections for example sinusitis and pharyngitis. Skin and soft tissue infections Read the complete document