Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
LEVAMISOLE HYDROCHLORIDE
Norbrook Laboratories Limited
QP52AE51
LEVAMISOLE HYDROCHLORIDE
1.5 %w/v
Oral Solution
LM-Licensed Merchant
Bovine, Ovine
Levamisole, combinations
Endoparasiticide
Authorised
1989-10-01
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10999/041/001 Case No: 7006152 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, NEWRY, 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 1.5% W/V SC WORM DRENCH 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 06/07/2010_ _CRN 7006152_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Levacide 1.5% w/v SC Worm Drench 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. A dark orange liquid. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle Sheep ACTIVE SUBSTANCE Levamisole (as levamisole hydrochloride) 1.5 % w/v EXCIPIENTS Methyl parahydroxybenzoate (E218) 0.15 % w/v Sodium metabisulphite (E223) 0.15 % w/v Tartrazine (E102) 0.011 % w/v IRISH MEDICINES BOARD __________________________________________________________________________ Izlasiet visu dokumentu