Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PYRANTEL EMBONATE
Intervet Ireland Limited
QP52AF02
11.4
Oral Paste
Endoparasiticide
Equine - Food
1998-06-26
IRISH MEDICINES BOARD ACT 1995, AS AMENDED EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 VPA: 10996/122/001 Case No: 7007922 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: INTERVET IRELAND LIMITED MAGNA DRIVE, MAGNA BUSINESS PARK, DUBLIN 24, 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: PYRATAPE P ORAL PASTE The particulars of which are set out in the attached Schedule. The authorisation is also subject to any special conditions as may be specified in the Schedule. The authorisation,unless revoked, shall continue in force from 21/06/2010. 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 22/06/2010_ _CRN 7007922_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pyratape P Oral Paste 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each syringe contains: ACTIVE SUBSTANCE Pyrantel embonate 11.4 g EXCIPIENTS Butylated Hydroxytoluene 0.0057 g For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Oral paste 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses and ponies. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the control and treatment of adult infections of large and small _Strongyles, Oxyuris, Parascaris _and _Anoplocephala_ _perfoliata_. 4.3 CONTRAIND Read the complete document