Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
BURSAL DISEASE VIRUS, INFECTIOUS (ATTENUATED STRAIN S706)
Merial Animal Health Limited
QI01AD09
BURSAL DISEASE VIRUS, INFECTIOUS (ATTENUATED STRAIN S706)
Per Cent
Lyophilisate for suspension
POM
Fowl - Chicken
Avian infectious bursal disease virus vaccine (Gumboro disease)
Immunological - Live Vaccine
Authorised
2006-12-21
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10857/049/001 Case No: 7005344 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: GALLIVAC IBD 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 15/05/2009. 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 16/05/2009_ _CRN 7005344_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT GALLIVAC IBD 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose contains: Active ingredient: Infectious Bursal Disease virus, attenuated strain S706, at least 10 4.0 CCID 50 Excipient : qs 1 dose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens (broilers, future layers and broiler breeders). 4.2 IN Read the complete document