Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
TYLOSIN TARTRATE
Huvepharma NV
QJ01FA90
100 %w/w
Granules for oral solution
Antibacterial
Bovine
2008-11-28
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA:10782/001/001 Case No: 7003196 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: HUVEPHARMA NV UITBREIDINGSTRAAT 80, 2600 ANTWERPEN, BELGIUM 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: PHARMASIN 100 %W/W WATER SOLUBLE GRANULES FOR ORAL SOLUTION FOR PIGS, BROILERS, PULLETS, TURKEYS AND CALVES 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 28/11/2008 to 27/11/2013. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/11/2008_ _CRN 7003196_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pharmasin 100% w/w Water Soluble Granules for oral solution for pigs, broilers, pullets, turkeys and calves 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tylosine tartrate: 100% w/w: 1100 gram granules contain 1100 gram tylosin tartrate corresponding to 1000 gram tylosin activity, equal to 1000 IU/mg. 3 PHARMACEUTICAL FORM Granules for oral solution. White to off-white coloured granules. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs, chickens (broilers, pullets), turkeys and calves. 4.2 INDI Διαβάστε το πλήρες έγγραφο