Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
DIHYDROSTREPTOMYCIN SULFATE
Alfasan Nederland B.V
QJ01GA90
DIHYDROSTREPTOMYCIN SULFATE
25 Per Cent
Solution for Injection
POM
Bovine
Dihydrostreptomycin
Antibacterial
Authorised
1988-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10980/004/001 Case No: 7005142 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: ALFASAN INTERNATIONAL B.V. KUIPERSWEG 9, 3449 JA WOERDEN, WOERDEN 3440AB, NETHERLANDS 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: DIHYDROSTREPTOMYCIN 25% 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 previously revoked, shall continue in force from 30/09/2008. 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 26/08/2009_ _CRN 7005142_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Dihydrostreptomycin 25% Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Indicated for the treatment of infections caused by or associated with dihydrostreptomyin susceptible organisms. 4.3 CONTRA Læs hele dokumentet