Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE
Norbrook Laboratories Limited
QJ01CA04
AMOXICILLIN TRIHYDRATE
400 Milligram
Tablets
POM
Bovine
Amoxicillin
Antibacterial
Authorised
1987-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/014/001 Case No: 7003347 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: NORBROOK LABORATORIES LIMITED STATION WORKS, CAMLOUGH ROAD, CO. DOWN BT35 6JP an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the Veterinary Medicinal Product: BETAMOX 400 MG TABLETS The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may be specified in the said Schedule. The authorisation, unless previously revoked, shall continue in force from 30/09/2007. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 31/07/2008_ _CRN 7003347_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Betamox 400 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Amoxicillin Trihydrate 0.460 g equivalent to 400.00 mg amoxicillin. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white oblong scored tablet 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Calves 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Betamox 400 mg Tablets are indicated for the treatment of Přečtěte si celý dokument