Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PYRANTEL EMBONATE
Pfizer Healthcare Ireland
QP52AF02
5.7 Grams
Granules
Endoparasiticide
Donkey
1989-10-01
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10019/010/001 Case No: 7006134 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: PFIZER HEALTHCARE IRELAND RINGASKIDDY, CO. CORK, 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: STRONGID-P GRANULES 5.7 G/SACHET 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 30/09/2009. 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 22/05/2010_ _CRN 7006134_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT STRONGID-P Granules 5.7 g/sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH SACHET CONTAINS: ACTIVE SUBSTANCE Pyrantel embonate 5.7 g For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Granules Pale yellow to buff free-flowing granules. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, ponies and foals over four weeks of age and donkeys. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES A broad spectrum anthelmintic for Read the complete document