Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
MARBOFLOXACIN CLOTRIMAZOLE DEXAMETHASONE ACETATE
Vetoquinol Ireland Limited
QS02CA06
Ear Drops Suspension
Antibacterial
Canine
2001-11-02
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10983/038/001 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: AURIZON EAR DROPS, SUSPENSION 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 18/12/2010. 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 AURIZON ear drops, suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ML OF AURIZON CONTAINS: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ear drops, suspension Homogenous beige to yellow oily suspension 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES - Treatment of otitis externa of both bacterial and fungal origin - respectively due to bacteria sensitive to marb Baca dokumen lengkapnya