البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE
Generics (UK) Limited
125 MG/5ml
Powder for Oral Suspension
1989-11-20
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0405/005/003 Case No: 2043367 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to GENERICS (UK) LIMITED 12 STATION CLOSE, POTTERS BAR, HERTFORDSHIRE EN6 1TL, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product GERAMOX 125MG/5 ML 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 30/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/05/2010_ _CRN 2043367_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Geramox 125mg/5ml Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml of reconstituted suspension contains Amoxicillin Trihydrate equivalent to 125mg of Amoxicillin. Excipients: Each 5ml contains 7.5mg aspartame and 548.5mg sorbitol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension. White to off white free flowing powder with an odour of raspberry. When reconstituted it readily produces a white to cream coloured completely homogenous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of inf اقرأ الوثيقة كاملة