Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
INFECTIOUS BOVINE RHINOTRACHEITIS VIRUS STRAIN LA INACTIVATED, PARAINFLUENZA-3 VIRUS STRAIN SF4 INACTIVATED, BOVINE DIARRHOEA VIRUS STRAIN NADL INACTIVATED, LIVE BOVINE RESPIRATORY SYNCITIAL VIRUS STRAIN LYM-56
Laboratorios Hipra S.A.
QI02AH
INFECTIOUS BOVINE RHINOTRACHEITIS VIRUS STRAIN LA INACTIVATED, PARAINFLUENZA-3 VIRUS STRAIN SF4 INACTIVATED, BOVINE DIARRHOEA VI
Per Cent
Pdr+Solv for Susp for Inj
POM
Bovine
Live and inactivated viral vaccines
Immunological - Mixed vaccine (live and inactivated)
Authorised
2003-06-06
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10846/003/001 Case No: 7004204 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: 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: HIPRABOVIS-4 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 05/06/2008. 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 18/02/2009_ _CRN 7004204_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT HIPRABOVIS-4 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Powder for reconstitution for suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle from 2 months of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES To stimulate active immunity against IBR, PI3, BVD and BRS viruses in cattle. For active immunisation of cattle to reduce clinical signs of Bovine Respiratory Syndrome associated with I Přečtěte si celý dokument