Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PRAZIQUANTEL PYRANTEL EMBONATE
Bayer Limited
QP52AA51
230/20.0 Milligram
Tablets
Endoparasiticide
Feline
2009-03-20
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA:10021/054/001 Case No: 7004270 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: BAYER LIMITED ANIMAL HEALTH DIVISION, THE ATRIUM, DUBLIN 18, IRELAND 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: BAYER CAT WORMER FILM-COATED 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 Part 2 of the said Schedule. This authorisation,unless previously revoked, shall continue in force from 20/03/2009 to 19/03/2014. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/03/2009_ _CRN 7004270_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bayer Cat Wormer Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet White to yellowish scored coated tablet. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of gastrointestinal roundworms and tapeworms: _Toxocara cati, Toxascaris leonina, Dipylidium caninum, Taenia taeniaeformis_. 4.3 CONTRAINDICATIONS Do not use simultaneously with piperazine Read the complete document