Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN
Vetoquinol Ireland Limited
QJ01MA93
MARBOFLOXACIN
1.0 %w/v
Pdr+Solv for Soln for Inj
POM
Canine, Feline
Marbofloxacin
Antibacterial
Authorised
2000-02-18
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10983/037/001 Case No: 7006206 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: VETOQUINOL IRELAND LIMITED 10 LAD LANE, LOWER BAGGOT STREET, DUBLIN 2, 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: MARBOCYL 1% SA, POWDER AND SOLVENT FOR SOLUTION FOR 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 05/06/2009 until 29/09/2013. 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 06/06/2009_ _CRN 7006206_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT MARBOCYL 1% SA, powder and solvent for solution for injection, for cats and dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Powder and solvent for solution for injection Pale yellow to pale beige powder and clear, colourless solvent 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats and dogs. Before reconstitution: POWDER Marbofloxacin 198.41 mg Disodium edetate 19.84 mg Benzalkonium chloride 1.98 mg Citiți documentul complet