Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
BOVINE PARAINFLUENZA 3 VIRUS (PI3), RLB103, ATTENUATED BOVINE RESPIRATORY SYNCYTIAL VIRUS (BRSV), STRAIN 375 ATTENUATED BOVINE VIRAL DIARRHOEA VIRUS (BVD), STRAIN 5960, KILLED BOVINE VIRAL DIARRHOEA VIRUS (BVD), STRAIN 6309, KILLED
Pfizer Healthcare Ireland
QI02AH
Lyophilisate for suspension for injection
Immunological - Mixed vaccine (live and inactivated)
Bovine
2005-06-03
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10019/103/001 Case No: 7006680 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: PFIZER HEALTHCARE IRELAND TRADING AS PFIZER ANIMAL HEALTH TRADING AS PFIZER ANIMAL HEALTH, RINGASKIDDY, CO. CORK, 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: RISPOVAL 3 BRSV PI3 BVD LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR CATTLE 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 26/03/2010. 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 14/04/2010_ _CRN 7006680_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Rispoval 3 BRSV Pi3 BVD Lyophilisate and suspension for suspension for injection for cattle. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. One dose (4 ml) contains: ACTIVE INGREDIENT(S): _LYOPHILISED Pročitajte cijeli dokument