Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Merial Animal Health Limited
QV07AB
Per Cent
Solution for Injection
POM
Fowl - Chicken
Solvents and diluting agents, incl. irrigating solutions
Immunological - Diluent
Authorised
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10857/069/001 Case No: 7006504 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: DILUMAREX 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 21/05/2010. 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 22/05/2010_ _CRN 7006504_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DILUMAREX. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Chickens. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In chickens: For the suspension preparation of MERIAL frozen vaccines against Marek’s disease. 4.3 CONTRAINDICATIONS Do not use alone. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL Read the complete document