Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
B & S Healthcare
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
250/125 Milligram
Tablets
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-01-13
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1328/089/001 Case No: 2060510 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to B & S HEALTHCARE UNIT 4, BRADFIELD ROAD, RUISLIP, MIDDLESEX, HA4 0NU, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product AUGMENTIN 250 MG/125 MG 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 08/05/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 12/05/2009_ _CRN 2060510_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin 250 mg/125 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amoxicillin trihydrate equivalent to 250 mg Amoxicillin with potassium clavulanate equivalent to 125 mg of clavulanic acid. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablets (tablet) Product imported from UK: White to off-white, oval shaped, film-coated tablets engraved 'Augmentin' on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 'Augmentin' is indicated for short term treatment of bacterial infections at the following sites when Amoxicillin resistant beta-lactamase Läs hela dokumentet