国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
DINOPROST (AS DINOPROST TROMETATOL PH.EUR.)
Ceva Santé Animale
QG02AD01
DINOPROST (AS DINOPROST TROMETATOL PH.EUR.)
5 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Dinoprost
Hormone
Authorised
2004-07-30
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10815/002/001 Case No: 7005023 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: CEVA SANTE ANIMALE Z.I. LA BALLASTIERE, 33500 LIBOURNE, FRANCE 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: ENZAPROST 5 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS. 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 12/06/2009. 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 13/06/2009_ _CRN 7005023_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT ENZAPROST 5 mg/ml Solution for injection for cattle and pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle: cows, heifers. Pigs: sows, gilts. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is indicated for its luteolytic effects in cattle and pigs. CATTLE The luteolytic ef 阅读完整的文件