국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
FLUNIXIN MEGLUMINE
Norbrook Laboratories Limited
QM01AG90
FLUNIXIN MEGLUMINE
5 %w/v
Solution for Injection
POM
Bovine, Equine - Food, Porcine
Flunixin
N.S.A.I.D
Authorised
1997-04-23
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10999/069/001 Case No: 7006713 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: FLUNIXIN INJECTION 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 revoked, shall continue in force from 29/09/2009. 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 30/09/2009_ _CRN 7006713_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Flunixin Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM A sterile aqueous solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses and pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Flunixin Injection is indicated for use in cattle and horses in the alleviation of inflammation and pain. In the horse, Flunixin Injection is indicated for the alleviation of inflammatory signs associated with musculo-skeletal disorders and f 전체 문서 읽기