FLUKIVER 5% W/V ORAL SUSPENSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
CLOSANTEL
Available from:
Janssen Cilag Ltd.
ATC code:
QP52AG09
Dosage:
5 %w/v
Pharmaceutical form:
Oral Suspension
Therapeutic group:
Endoparasiticide
Therapeutic area:
Ovine
Authorization date:
1989-10-01
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
VPA: 10545/011/001
Case No: 7008205
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:
FLUKIVER 5% W/V ORAL SUSPENSION
The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in
the Schedule.
The authorisation,unless revoked, shall continue in force from 21/07/2010.
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 22/07/2010_
_CRN 7008205_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver 5% w/v Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Closantel (as Clostanel sodium)
50 mg/ml
Excipients:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
A white suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep and lambs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of adult and immature liver fluke, haematophagous nematodes and larval stages of some
arthr
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