Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
LEVAMISOLE
Norbrook Laboratories Limited
QP52AE01
LEVAMISOLE
200 Mg/Ml
Pour-on Solution
LM-Licensed Merchant
Bovine
Levamisole
Endoparasiticide
Authorised
1997-12-12
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/070/001 Case No: 7003720 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: NORBROOK LABORATORIES LIMITED STATION WORKS, CAMLOUGH ROAD, CO. DOWN BT35 6JP 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: LEVACIDE POUR-ON 200MG/ML 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 11/12/2007. 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 10/10/2008_ _CRN 7003720_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Levacide Pour-on 200mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Levamisole (as lavamisole hydrochloride) 200 mg/ml Excipients: Patent Blue (E131) 1 mg/ml For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Pour-on Solution A dark blue non-aqueous solution for external use. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Levacide Pour-on is a Les hele dokumentet