Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MYCOPLASMA HYOPNEUMONIAE INACTIVATED
Merial Animal Health Limited
QI09AB13
2 Millilitre
Suspension for Injection
Immunological - Inactivated vaccine
Porcine
1999-12-23
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10857/030/001A Case No: 7004763 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: HYORESP 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 10/06/2008. 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 13/06/2008_ _CRN 7004763_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT HYORESP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Per one dose of 2 ml: ACTIVE SUBSTANCE: . Inactivated whole cell _Mycoplasma hyopneumoniae _antigen, at least ...................... 3.0 ELISA.U * ADJUVANT: . Al +++ (as hydroxide) .......................................................................................................... 4.2 mg EXCIPIENTS: . Thiomersal .............................................................................................. Read the complete document