Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
IMIDAPRIL
Vetoquinol Ireland Limited
QC09AA
150 Milligram
Powder for Oral Solution
Cardiovascular
2003-04-17
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10983/039/002 Case No: 7006206 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: VETOQUINOL IRELAND LIMITED 10 LAD LANE, LOWER BAGGOT STREET, DUBLIN 2, 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: PRILIUM 150 MG POWDER FOR ORAL SOLUTION FOR DOGS 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 revoked, shall continue in force from 05/06/2009. 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 06/06/2009_ _CRN 7006206_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT PRILIUM 150 mg powder for oral solution for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Powder for oral solution. Vial containing a white powder. After reconstitution, the solution is limpid and colourless. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs weighing over 4 kg 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: treatment of moderate to severe heart failure caused by mitral regurgitation or Läs hela dokumentet