Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
SELENIUM
Novartis Animal Health UK Ltd
QA12CE
50 Mg/Ml
Suspension for Injection
Vitamins & Minerals
Bovine
2010-04-16
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA:10825/025/001 Case No: 7000077 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: NOVARTIS ANIMAL HEALTH UK LTD FRIMLEY BUSINESS PARK, FRIMLEY, SURREY GU16 7SR, ENGLAND 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: DEPOSEL MULTIDOSE 50 MG/ML SUSPENSION 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 Part 2 of the said Schedule. This authorisation,unless previously revoked, shall continue in force from 16/04/2010 to 15/04/2015. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/04/2010_ _CRN 7000077_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Deposel Multidose 50 mg/ml Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Suspension for injection. Smooth, yellow aqueous suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment and prevention of selenium deficiency in sheep and cattle for up to 12 months. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not exceed the recommended dosage. ACTIVE INGREDIENTS: Selen Lugege kogu dokumenti