Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
BOVINE VIRAL DIARRHOEA VIRUS (BVD), STRAIN 5960, KILLED
Pfizer Healthcare Ireland
QI02AA01
Emulsion for Injection
Immunological - Inactivated vaccine
Bovine
2005-04-13
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10019/104/001 Case No: 7005418 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, 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: PREGSURE BVD 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 previously revoked, shall continue in force from 13/11/2009. 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 14/11/2009_ _CRN 7005418_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT PregSure BVD Emulsion for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains: ACTIVE SUBSTANCE: inactivated Bovine Viral Diarrhoea (BVD) type 1 virus, cytopathogenic strain 5960; to induce a geometric mean seroneutralizing titre in guinea pigs of at least 5.6 log 2 ADJUVANT: Procision-A™ : 0.164 ml/dose of vaccine Composition of Procision-A™ (per ml) Quil A 3.05 mg Cholesterol 3.0 Leggi il documento completo