Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
LUFENURON
Novartis Animal Health Ireland Ltd
QP53BC01
409.8 Milligram
Tablets
Ectoparasiticide
Canine
1999-06-20
IRISH MEDICINES BOARD ACT 1995 ANIMAL REMEDIES REGULATIONS, 2005 (S.I. NO. 734 OF 2005) VPA: 10835/024/003 Case No: 7001566 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: NOVARTIS ANIMAL HEALTH INDUSTRIAL PARK, CORK ROAD, WATERFORD 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: PROGRAM TABLETS 409.8MG 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 this ________________ 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 10/10/2006_ _CRN 7001566_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Program Tablets, 409.8 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active Substance Lufenuron 204.9 mg Excipients Titanium dioxide PH (E171) 2.8 mg Iron Oxide brown 17278 (E172) 0.5 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Violet white, round slightly biconvex film coated tablets embossed on one side ‘CGV’ and ‘FMF’ on the other. Each tablet contains 409.8mg Lufenuron. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the prevention of flea infestation on dogs. Susceptibl Прочитать полный документ