Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FIPRONIL
Merial Animal Health Limited
QP53AX15
0.25 %w/v
Cutaneous Spray Solution
Ectoparasiticide
Canine
1995-07-07
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 Read the complete document