Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVAMISOLE
Chem-Pharm
QP52AE01
LEVAMISOLE
75 Mg/Ml
Solution for Injection
LM-Licensed Merchant
Bovine, Ovine
Levamisole
Endoparasiticide
Authorised
1999-10-01
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10823/010/001 Case No: 7006772 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: CHEM-PHARM BALLYVAUGHAN, CO. CLARE, IRELAND 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: LEVAPHARM INJECTION 75 MG/ML The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in the Schedule. The authorisation,unless revoked, shall continue in force from 30/09/2009. 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 23/07/2010_ _CRN 7006772_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Levapharm Injection 75 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear sterile solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is a broad spectrum anthelmintic for use in the treatment and control of nematode infections. It should be used in cases of parasitic gastro-enteritis and lungworm disease caused by mature and developing immature forms of Read the complete document