Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
McDowell Pharmaceuticals
500 Milligram
Modified-release Tablets
2010-02-05
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1473/040/001 Case No: 2071611 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MCDOWELL PHARMACEUTICALS 4 ALTONA ROAD, LISBURN, N. IRELAND, BT27 5QB 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 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 05/02/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/02/2010_ _CRN 2071611_ _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 Clarithromycin 500mg Excipients- contains Lactose Monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified Release Tablet _Product imported from the UK:_ Yellow, ovaloid modified release 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 pharyngiti Read the complete document