Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OXYTOCIN
Laboratorios Hipra S.A.
QH01BB02
OXYTOCIN
10 International Unit
Solution for Injection
POM
Bovine, Canine, Feline, Ovine, Porcine
Oxytocin
Hormone
Authorised
2000-09-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007 (S.I. NO. 144 OF 2007) VPA: 10846/002/001 Case No: 7003219 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 144 of 2007) hereby grants to: LABORATORIOS HIPRA S.A. AVDA. LA SELVA 135, 17170 - AMER (GIRONA), SPAIN 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: HIPRACIN 10IU/ML SYNTHETIC OXYTOCIN, SOLUTION 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 11/09/2007. 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 01/09/2007_ _CRN 7003219_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRACIN 10 IU/ml Synthetic Oxytocin, solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sows, Ewes, Cows, Bitches, and Queens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In general, for all target species: Stimulation of uterine contractions to facilitate parturition in the pre Read the complete document