AUROFAC 100 GRANULAR PREMIX FOR MEDICATED FEEDING
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-05-2024
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Active ingredient:
CHLORTETRACYCLINE HYDROCHLORIDE
Available from:
Alpharma BVBA
ATC code:
QJ01AA03
Dosage:
100 mg/g
Pharmaceutical form:
Premix for Med.Feedstuffs
Therapeutic group:
Antibacterial
Therapeutic area:
Fowl - Chicken
Authorization date:
2001-04-22
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10802/001/001
Case No: 7007489
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:
ALPHARMA BVBA
LAARSTRAAT 16, 2610 ANTWERP, 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:
AUROFAC 100 GRANULAR PREMIX FOR MEDICATED FEEDING
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 22/03/2010.
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 23/03/2010_
_CRN 7007489_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Aurofac 100 Granular Premix for Medicated Feedingstuff
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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, chickens, turkeys and ducks.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an aid in the treatment and control of respiratory and systemic infections associated with chlortetracycline-sensitive
organisms.
4.3 CONTRAI
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