Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Levamisole hydrochloride
Chem-Pharm Limited
QP52AE01
Levamisole hydrochloride
75 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Sheep
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.) I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _3_ _/_ _0_ _7_ _/_ _2_ _0_ _1_ _0_ _C_ _R_ _N_ _ _ _7_ _0_ _0_ _6_ _7_ _7_ _2_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _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 Perskaitykite visą dokumentą