Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
MAREK HVT STRAIN F#126
Pfizer Healthcare Ireland
QI01AD03
Powder for reconstitution
Immunological - Live Vaccine
Fowl - Chicken
2010-05-14
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) 10019/178/001 Case No: 7007814 Transferred from 10861/061/001. The Irish Medicines Board in exercise of the powers conferred on it by the Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: PFIZER HEALTHCARE IRELAND RINGASKIDDY, CO. CORK, IRELAND 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: POULVAC MAREK HVT 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 14/05/2010. 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 27/05/2010_ _CRN 7007814_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Poulvac Marek HVT. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Powder for reconstitution for solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Day old chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of chickens to reduce lesions of Marek’s Disease. The onset of immunity occurs two weeks after vaccination. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not vaccinate diseased chic Read the complete document