FLUBENOL EASY 220 MG CHEWABLE TABLETS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-05-2024
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Active ingredient:
FLUBENDAZOLE
Available from:
Janssen Cilag Ltd.
ATC code:
QP52AC12
Dosage:
220 Milligram
Pharmaceutical form:
Tablets Chewable
Therapeutic group:
Endoparasiticide
Therapeutic area:
Canine
Authorization date:
2004-11-05
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
ANIMAL REMEDIES REGULATIONS, 2005
(S.I. NO. 734 OF 2005)
VPA: 10545/026/001
Case No: 7002058
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) hereby grants to:
JANSSEN CILAG LTD.
SAUNDERTON, HIGH WYCOMBE, BUCKINGHAMSHIRE HP14 4HJ, 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:
FLUBENOL EASY 220 MG CHEWABLE TABLETS
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.
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 10/11/2006_
_CRN 7002058_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flubenol Easy 220 mg Chewable tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active substance
Flubendazole
220 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of adult worm infestations in dogs with:
ROUNDWORMS
_Toxocara canis_
_Toxascaris leonina_
HOOKWORMS
_Uncinaria stenocephala_
_Ancylostoma caninum_
WHIPWORM
_Trichuris vulpis_
TAPEWORM
_Taenia pisiformis_
4.3 CONTRAINDICATIONS
Do not use in anima
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