Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
PROPOFOL
Schering Plough Limited
QN01AX10
10 Mg/Ml
Emulsion for Injection
Neurological Preparations
Canine
1989-07-05
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10277/030/001 Case No: 7006071 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: SCHERING PLOUGH LIMITED SHIRE PARK, WELWYN GARDEN CITY, HERTFORDSHIRE AL7 1TW, UNITED KINGDOM 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: RAPINOVET 10 MG/ML EMULSION 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 revoked, shall continue in force from 06/11/2009. 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 07/11/2009_ _CRN 7006071_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Rapinovet 10 mg/ml Emulsion for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Propofol 10mg For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Emulsion for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES A short-acting, intravenous, general anaesthetic for procedures of short duration, lasting up to five min Les hele dokumentet