Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVAMISOLE HYDROCHLORIDE
Bimeda Chemicals
QP52AE01
LEVAMISOLE HYDROCHLORIDE
7.5 Mg/Ml
Solution for Injection
LM-Licensed Merchant
Bovine, Ovine
Levamisole
Endoparasiticide
Authorised
1989-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10126/015/001 Case No: 7006243 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: BIMEDA CHEMICALS BROOMHILL ROAD, TALLAGHT, DUBLIN 24., 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: VERMISOLE 75 MG/ML SOLUTION FOR INJECTION 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 30/09/2009. 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 01/05/2010_ _CRN 7006243_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Vermisole 75 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. A clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and control of lungworms, stomach and bowel worm infestation (except inhibited Ostertagia) in Read the complete document