Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ESTRADIOL BENZOATE
Intervet Ireland Limited
QG03CA03
0.2 Mg/Ml
Solution for Injection
Hormone
Canine
2000-01-21
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10996/076/001 Case No: 7006440 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: INTERVET IRELAND LIMITED MAGNA DRIVE, MAGNA BUSINESS PARK, DUBLIN 24, 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: MESALIN SOLUTION FOR INJECTION, 0.2MG/ML 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 20/01/2010. 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 01/04/2010_ _CRN 7006440_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Mesalin Solution for Injection, 0.2mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless to pale yellow, sterile, oily, non-aqueous solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (bitches). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Mesalin is indicated solely for the prevention of pregnancy following mis-mating (mesalliance) i Prečítajte si celý dokument