国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE CLAVULANATE POTASSIUM
LTT Pharma Limited
250/125 Milligram
Tablets
2009-10-16
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PPA1562/009/001 Case No: 2064086 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to LTT PHARMA LIMITED UNIT 18, OXLEASOW ROAD, EAST MOON MOAT, REDDITCH, WORCESTERSHIRE B98 0RE, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product AUGMENTIN TABLETS 250 MG/125 MG 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 16/10/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 23/10/2009_ _CRN 2064086_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Augmentin Tablets 250 mg/125 mg 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 the 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 amoxic 阅读完整的文件