FRONTLINE SPRAY 0.25% W/V
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
FIPRONIL
Available from:
Merial Animal Health Limited
ATC code:
QP53AX15
Dosage:
0.25 %w/v
Pharmaceutical form:
Cutaneous Spray Solution
Therapeutic group:
Ectoparasiticide
Therapeutic area:
Canine
Authorization date:
1995-07-07
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007
(S.I. NO. 786 OF 2007)
VPA: 10857/010/001A
Case No: 7007203
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:
MERIAL ANIMAL HEALTH LIMITED
SANDRINGHAM HOUSE, SANDRINGHAM AVENUE, HARLOW BUSINESS PARK, HARLOW, ESSEX CM19 5TG, 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:
FRONTLINE SPRAY 0.25% W/V
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 previously revoked, shall continue in force from 16/04/2010.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/04/2010_
_CRN 7007203_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Frontline Spray 0.25% w/v
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Fipronil
0.25 % w/v
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous spray, solution.
A clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs, cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The treatment and prevention of infestation by fleas an
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