Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
CLARITHROMYCIN
Rowex Ltd
125/5
Oral Suspension
2006-04-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0711/061/003 Case No: 2070934 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to ROWEX LTD BANTRY, CO. CORK, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CLOROM, 125/5 MICROMOL 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 07/09/2009 until 12/04/2011. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 07/09/2009_ _CRN 2070934_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clorom 125 mg/5 ml granules for oral suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of the suspension contains clarithromycin 125 mg. 1 ml of the suspension contains clarithromycin 25 mg. For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Granules for oral suspension. White to off-white granules forming a 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 acquired pneumonia. - Upper respiratory tract infec Leggi il documento completo