Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
TYLOSIN
Elanco Animal Health, Eli Lilly and Company Limited
QJ01FA90
100
Premix for Med.Feedstuffs
Antibacterial
Porcine
1988-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10047/004/002 Case No: 7004284 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: ELANCO ANIMAL HEALTH, ELI LILLY AND COMPANY LIMITED PRIESTLY ROAD, BASINGSTOKE, HAMPSHIRE RG24 9NL, 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: TYLAN G100 PREMIX 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 30/06/2008 until 30/09/2008. 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 05/07/2008_ _CRN 7004284_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tylan G100 Premix 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each kg contains: Active Substance Tylosin activity as tylosin phosphate 100 g For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Premix for medicated feeding stuff 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the prevention and control of swine dysentery and enzootic pneumonia. For the treatme Baca dokumen lengkap