PHARMASIN FOR PIGS, BROILERS, PULLETS, TURKEYS AND
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-05-2024
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Active ingredient:
TYLOSIN TARTRATE
Available from:
Huvepharma NV
ATC code:
QJ01FA90
Dosage:
100 %w/w
Pharmaceutical form:
Granules for oral solution
Therapeutic group:
Antibacterial
Therapeutic area:
Bovine
Authorization date:
2008-11-28
Summary of Product characteristics
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
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