Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
FLUBENDAZOLE
Janssen Cilag Ltd.
QP52AC12
220 Milligram
Tablets Chewable
Endoparasiticide
Canine
2004-11-05
IRISH MEDICINES BOARD ACT 1995 ANIMAL REMEDIES REGULATIONS, 2005 (S.I. NO. 734 OF 2005) VPA: 10545/026/001 Case No: 7002058 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) hereby grants to: JANSSEN CILAG LTD. SAUNDERTON, HIGH WYCOMBE, BUCKINGHAMSHIRE HP14 4HJ, 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: FLUBENOL EASY 220 MG CHEWABLE TABLETS 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 10/11/2006_ _CRN 7002058_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flubenol Easy 220 mg Chewable tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active substance Flubendazole 220 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of adult worm infestations in dogs with: ROUNDWORMS _Toxocara canis_ _Toxascaris leonina_ HOOKWORMS _Uncinaria stenocephala_ _Ancylostoma caninum_ WHIPWORM _Trichuris vulpis_ TAPEWORM _Taenia pisiformis_ 4.3 CONTRAINDICATIONS Do not use in anima Olvassa el a teljes dokumentumot