DICLAZURIL JANSSEN 2.5 MG/ML ORAL SUSPENSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
17-05-2024
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Active ingredient:
DICLAZURIL
Available from:
Janssen Cilag Ltd.
ATC code:
QP51AJ03
Dosage:
2.5 Mg/Ml
Pharmaceutical form:
Oral Suspension
Therapeutic group:
Coccidiostats
Therapeutic area:
Bovine
Authorization date:
2008-06-13
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10545/036/001
Case No: 7005738
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:
JANSSEN CILAG LTD.
50-100 HOLMERS FARM WAY, HIGH WYCOMBE, BUCKINGHAMSHIRE HP12 4EG, UNITED KINGDOM
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:
DICLAZURIL JANSSEN 2.5 MG/ML ORAL SUSPENSION
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 05/06/2009 until 12/06/2013.
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 06/06/2009_
_CRN 7005738_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Diclazuril Janssen 2.5 mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
White, oral suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Ovine (lambs) and bovine (calves).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In lambs:
Prevention of coccidiosis caused by _Eimeria crandallis _and _Eimeria ovinoidalis_.
In calves:
Prevention of coccidiosis caused by _Eimeria bovis
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