Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Ranbaxy Ireland Limited
250/5 MG/5ml
Oral Suspension
2006-06-02
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0408/063/004 Case No: 2043628 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to RANBAXY IRELAND LIMITED SPAFIELD, CORK ROAD, CASHEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CLARITHROMYCIN 250MG/5ML ORAL SUSPENSION 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 13/12/2007 until 31/05/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/01/2008_ _CRN 2043628_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarithromycin 250 mg/5ml Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of the suspension contains clarithromycin 250 mg. 1 ml of the suspension contains clarithromycin 50 mg. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Granules for oral suspension. White to off-white granules forming white to off-white suspension on reconstitution with water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the following infections in children when caused by clarithromycin-susceptible organisms: - Lower respiratory tract infections such as community acquir Read the complete document