מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
NITROSCANATE
Novartis Animal Health Ireland Ltd
QP52AX01
500 Milligram
Tablets
Endoparasiticide
Canine
1999-10-01
IRISH MEDICINES BOARD ACT 1995 ANIMAL REMEDIES REGULATIONS, 2005 (S.I. NO. 734 OF 2005) VPA: 10835/013/001 Case No: 7001565 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: LOPATOL 500MG TABLET 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 7001565_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Lopatol 500mg Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Active Substance: Nitroscanate 500mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Tablet 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Lopatol is a broad spectrum anthelmintic for use in dogs. It is highly effective against intestinal stages of the following nematodes and cestodes Toxocara canis Toxacaris leonina Ancylostoma caninum Uncinaria stenocephala Taenia ovis Taenia hydatigenia Taenia pisiformis and Dipylidium caninum 4.3 CONTRAINDICATIO קרא את המסמך השלם