Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
IVERMECTIN
C-CORP Ltd
QP54AA01
IVERMECTIN
0.5 %w/v
Pour-on Solution
LM-Licensed Merchant
Bovine
Ivermectin
Endectoparasiticides
Authorised
2001-01-26
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10831/006/001 Case No: 7000831 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: C-CORP LTD 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: MASTERMECTIN 0.5% POUR-ON SOLUTION FOR CATTLE 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 26/01/2006. 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 01/03/2008_ _CRN 7000831_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Mastermectin 0.5% Pour-On Solution for Cattle. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, please see Section 6.1 3 PHARMACEUTICAL FORM Pour-on solution. A clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. Each 1ml contains: ACTIVE SUBSTANCE: Ivermectin Ph.Eur. 0.5% w/v EXCIPIENTS: Benzyl alcohol Ph.Eur. 1% w/v IRISH MEDICINES BOARD _________________________________________ Read the complete document