Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
AGLEPRISTONE
Virbac S.A.
QG03XB90
AGLEPRISTONE
30 Mg/Ml
Solution for Injection
POM
Canine
Aglepristone
Hormone
Authorised
2004-05-07
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10988/066/001 Case No: 7004829 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: VIRBAC S.A. VIRBAC 1, 1 ERE AVENUE, 2065 M - L.I.D., BP 27, 06516, CARROS CEDEX, 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: ALIZIN 30MG/ML SOLUTION FOR INJECTION The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in the Schedule. The authorisation,unless revoked, shall continue in force from 26/11/2008. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/09/2010_ _CRN 7004829_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Alizin 30mg/ml Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Clear, yellow oily solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs (bitches). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Pregnant bitches: induction of abortion up to 45 days after mating. 4.3 CONTRAINDICATIONS Do not use in dogs with impaired hepatic or renal function, in diabetic animals or in dogs in poor health. Do not use in d Read the complete document