Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE DIHYDRATE
Franklin Pharmaceuticals Ltd.
QJ01AA06
200 Mg/Ml
Solution for Injection
Antibacterial
Bovine
2000-10-27
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10976/016/001 Case No: 7007556 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: FRANKLIN PHARMACEUTICALS LTD. ATHBOY ROAD, TRIM, CO. MEATH, 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: OXYTETRAJECT 200 LA 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 31/03/2010 until . 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 01/04/2010_ _CRN 7007556_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Oxytetraject 200 LA Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance Oxytetracycline 200 mg (as Oxytetracycline dihydrate) 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Oxytetraject 200 Long Acting is indicated in the treatment and control of diseases caused by or associated with organisms Prečítajte si celý dokument