PROGRAM TABLETS 409.8MG
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
LUFENURON
Available from:
Novartis Animal Health Ireland Ltd
ATC code:
QP53BC01
Dosage:
409.8 Milligram
Pharmaceutical form:
Tablets
Therapeutic group:
Ectoparasiticide
Therapeutic area:
Canine
Authorization date:
1999-06-20
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
ANIMAL REMEDIES REGULATIONS, 2005
(S.I. NO. 734 OF 2005)
VPA: 10835/024/003
Case No: 7001566
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:
NOVARTIS ANIMAL HEALTH
INDUSTRIAL PARK, CORK ROAD, WATERFORD
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:
PROGRAM TABLETS 409.8MG
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 this
________________
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 10/10/2006_
_CRN 7001566_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Program Tablets, 409.8 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active Substance
Lufenuron
204.9 mg
Excipients
Titanium dioxide PH (E171)
2.8 mg
Iron Oxide brown 17278 (E172)
0.5 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Violet white, round slightly biconvex film coated tablets embossed on one side ‘CGV’ and ‘FMF’ on the other. Each
tablet contains 409.8mg Lufenuron.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention of flea infestation on dogs.
Susceptibl
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