Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE HYDROCHLORIDE
Alfasan Nederland B.V
QJ01AA06
OXYTETRACYCLINE HYDROCHLORIDE
10 Per Cent
Solution for Injection
POM
Bovine
Oxytetracycline
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: 10980/001/001 Case No: 7004423 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: OXYTETRACYCLINE INJECTION 10% 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 25/08/2009_ _CRN 7004423_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Oxytetracycline Injection 10% 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 For the treatment of pneumonia and shipping fever complex caused by organisms sensitive to oxytetracycline including _Pasteurella _spp., _Haemophilus _spp., Read the complete document