Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CLOXACILLIN
Norbrook Laboratories Limited
QJ51CF02
CLOXACILLIN
200 Mg/Dose
intramammary Suspension
POM
Bovine
Cloxacillin
Antibacterial
Authorised
1987-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/002/001 Case No: 7003617 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: NOROCLOX QR 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 30/09/2007. 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 11/08/2009_ _CRN 7003617_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Noroclox QR 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single dose 5 g syringe contains: ACTIVE SUBSTANCE Cloxacillin (as Sodium Salt) 200 mg For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Intramammary suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cows 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of clinical mastitis in lactating cows caused by the following Gram-positive organisms: _Streptoc Read the complete document