Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
LEVAMISOLE HYDROCHLORIDE
Norbrook Laboratories Limited
QP52AE01
LEVAMISOLE HYDROCHLORIDE
75 Mg/Ml
Oral Solution
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: 10999/038/001 Case No: 7007615 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 LOW VOLUME WORM DRENCH 75 MG/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 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 24/03/2010_ _CRN 7007615_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Levacide Low Volume Worm Drench 75 mg/ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral solution. A yellow viscous solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle Sheep Each ml contains: Active Substance Levamisole (as levamisole hydrochloride) 75 mg Excipients Methyl Parahydroxybenzoate (E218) 1.5 mg Tartrazine (E102) 0.11 mg Sodium Metabisulphite 1.5 Baca dokumen lengkapnya