Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
HYALURONATE SODIUM
Bayer Limited
QM09AX01
10 Mg/Ml
Solution for Injection
N.S.A.I.D
Equine - Food
1997-04-23
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10021/033/001 Case No: 7006830 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: BAYER LIMITED ANIMAL HEALTH DIVISION, THE ATRIUM, DUBLIN 18, 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: HYONATE 10 MG/ML SOLUTION FOR INJECTION 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 16/07/2010. 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 20/07/2010_ _CRN 7006830_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Hyonate 10 mg/ml solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE CONSTITUENTS Sodium hyaluronate 10 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear, colourless liquid. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of lameness in horses due to non-infectious inflammation of joints 4.3 CONTRAINDICATIONS None known. 4.4 SPECIAL WARNINGS F Lugege kogu dokumenti