Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CEFALEXIN
Sogeval
QJ01DB01
300 Milligram
Tablets
Antibacterial
Canine
2010-04-16
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10814/005/002 Case No: 7008096 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: SOGEVAL 200 AVENUE DE MAYENNE, BP 2227, 53002 LAVAL CEDEX 9, FRANCE 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: THERIOS 300MG PALATABLE TABLETS FOR DOGS The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in the Schedule. The authorisation,unless revoked, shall continue in force from 05/08/2010 until 15/04/2015. 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 07/08/2010_ _CRN 7008096_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Therios 300 mg palatable tablets for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Tablet. Round scored beige palatable tablet. The tablet can be divided into equal halves and quarters. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of bacterial skin infections in dogs (including deep and superficial pyoderma) caused by organisms sensitive to cefalexin. For the treatment of urinary tr Read the complete document