APRALAN G100 PREMIX
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
APRAMYCIN SULPHATE
Available from:
Elanco Animal Health, Eli Lilly and Company Limited
ATC code:
QJ01GB90
Dosage:
100
Pharmaceutical form:
Premix for Med.Feedstuffs
Therapeutic group:
Antibacterial
Therapeutic area:
Porcine
Authorization date:
1988-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10047/013/001
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:
APRALAN 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
APRALAN G 100 Premix
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Premix for medicated feed.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
APRALAN G 100 Premix is indicated for use in young pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of bacterial enteritis in young pigs caused by Escherichia coli and other apramyci
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