国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE
Pfizer Healthcare Ireland
QJ01CA04
150 Mg/Ml
Suspension for Injection
Antibacterial
Bovine
1997-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10019/044/001 Case No: 7003446 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: PFIZER HEALTHCARE IRELAND TRADING AS PFIZER ANIMAL HEALTH, RINGASKIDDY, CO. CORK, IRELAND 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: CLAMOXYL READY-TO-USE 150 MG/ML SUSPENSION FOR INJECTION 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 01/04/2008_ _CRN 7003446_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Clamoxyl Ready-To-Use 150 mg/ml Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active substance Amoxicillin (as amoxicillin trihydrate) 150 mg/ml For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs, cats, sheep, pigs and cattle. 4.2 INDICATIONS FOR USE, SPECIFYING T 完全なドキュメントを読む