Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
INACTIVATED BOVINE CORONAVIRUS STRAIN F15, INACTIVATED BOVINE ROTAVIRUS STRAIN RO1, INACTIVATED E.COLI K99 STRAIN SEROTYPE O101, INACTIVATED E.COLI Y STRAIN SEROTYPE O117, INACTIVATED E.COLI F41 STRAIN SEROTYPE O101, E.COLI 31A ANTIGEN
Merial Animal Health Limited
QI02AL01
INACTIVATED BOVINE CORONAVIRUS STRAIN F15, INACTIVATED BOVINE ROTAVIRUS STRAIN RO1, INACTIVATED E.COLI K99 STRAIN SEROTYPE O101,
Unknown
Suspension for Injection
LM-Licensed Merchant
Bovine
Inactivated Bovine rotavirus vaccine + inactivated Bovine coronavirus vaccine + inactivated Escheri
Immunological - Inactivated vaccine
Authorised
2003-08-06
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10857/032/001 Case No: 7004880 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: MERIAL ANIMAL HEALTH LIMITED SANDRINGHAM HOUSE, SANDRINGHAM AVENUE, HARLOW BUSINESS PARK, HARLOW, ESSEX CM19 5TG, 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: TRIVACTON 6 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 30/01/2009. 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 31/01/2009_ _CRN 7004880_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT TRIVACTON 6. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION * 1SA.U = q.s. to obtain to obtain a seroagglutinating antibody titre of 1 log 10 in mice after one administration of vaccine. ** 1SN.U = q.s. to obtain a seroneutralising antibody titre of 1 log 10 in guinea-pigs after two administrations of vaccine. For a full list of excipients, see section 6.1 Each 5 ml of vaccine contains: Active substance(s): Inactivated E. coli (ant Прочитайте повний документ