Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
OXFENDAZOLE, COBALTOUS SULFATE, SELENIUM
Norbrook Laboratories Limited
QP52AC02
OXFENDAZOLE, COBALTOUS SULFATE, SELENIUM
5 Per Cent
Oral Suspension
LM-Licensed Merchant
Ovine
Oxfendazole
Endoparasiticide
Authorised
1997-02-07
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/066/001 Case No: 7001684 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: PARAFEND 5% SC 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 06/02/2007. 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 16/01/2009_ _CRN 7001684_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT PARAFEND 5% SC 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredients of Parafend 5.0% SC are Oxfendazole 50.0 mg/ml, elemental selenium 1.1 mg/ml (as anhydrous sodium selenate) and elemental cobalt 3.69 mg/ml (as cobalt sulphate). Sodium Methyl Hydroxybenzoate 0.18 % w/v is included as a preservative. For a full list of excipients see 6.1 3 PHARMACEUTICAL FORM Oral Suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep. IRISH MEDI Läs hela dokumentet