Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
IVERMECTIN
Eco Animal Health Limited
QP54AA01
1 %w/v
Solution for Injection
Endectoparasiticides
Bovine
2004-11-26
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) REGULATIONS 2007 (S.I. NO. 144 OF 2007) VPA: 10859/011/001 Case No: 7001623 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 144 of 2007) hereby grants to: ECO ANIMAL HEALTH LIMITED 78 COOMBE ROAD, NEW MALDEN, SURREY KT3 4QS, 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: FATROMECTIN 1% SOLUTION FOR INJECTION 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. 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 27/04/2007_ _CRN 7001623_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Fatromectin 1% Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection-Clear, colourless solution 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES CATTLE: For the treatment of gastrointestinal nematodes, lungworms, eyeworms, warble flies, mites and lice (as shown below) of beef and non-lactating dairy cattle: Gastrointestinal worms (adults and 4 th stage larvae): _Osterta Lire le document complet