מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
LIVE PNEUMOVIRUS PL21 STRAIN
Merial Animal Health Limited
QI01AD01
LIVE PNEUMOVIRUS PL21 STRAIN
Unknown
Lyophilisate for suspension
POM
Fowl - Chicken
Avian rhinotracheitis virus vaccine
Immunological - Live Vaccine
Authorised
2000-06-08
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10857/035/001 Case No: 7006308 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: NEMOVAC The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in the Schedule. The authorisation,unless revoked, shall continue in force from 17/12/2009. 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 23/06/2010_ _CRN 7006308_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT NEMOVAC 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of reconstituted vaccine contains: ACTIVE SUBSTANCE: Live pneumovirus, PL21 strain, at least 2.3 log 10 CCID 50 CCID 50 = 50% cell culture infective dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate for suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Broiler chickens between 7 and 14 days. Breeder and layer pullets from 14 weeks of age. 4.2 INDICATIONS FOR USE, SPECIFYING קרא את המסמך השלם