Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
Clonmel Healthcare Ltd
125/62.5 Milligram
Powder for Oral Suspension
1999-09-17
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0126/103/003 Case No: 2051983 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CLONMEL HEALTHCARE LIMITED WATERFORD ROAD, CLONMEL, CO. TIPPERARY, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product CLAVAMEL 125MG/62.5MG PER 5ML JUNIOR POWDER FOR 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 26/06/2008 until 16/09/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 27/06/2008_ _CRN 2051983_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clavamel 125 mg/62.5 mg per 5 ml Junior Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of reconstituted suspension contains Amoxicillin Trihydrate equivalent to 125 mg of amoxicillin and potassium clavulanate equivalent to 62.5mg of clavulaic acid. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension Clear, glass bottles, containing a white to off-white powder for reconstitution with water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clavamel is indicated for short term treatment of bacterial infections at the fol Lees het volledige document