Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DOPEXAMINE HYDROCHLORIDE
Cephalon Limited
10
Concentrate for Soln for Inf
2006-06-23
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA1260/004/001 Case No: 2071684 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to CEPHALON LIMITED 1 ALBANY PLACE, HYDE WAY, WELWYN GARDEN CITY, HERTFORDSHIRE AL7 3BT, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations, in respect of the product DOPACARD 10MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 13/04/2010. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 13/04/2010_ _CRN 2071684_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dopacard 10mg/ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml ampoule contains 50mg dopexamine hydrochloride (10mg/ml). For a full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Concentrate for solution for infusion. Colourless liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dopacard is indicated for short term administration (experience in clinical studies has included administration for up to 48h) to patients who require peripheral vasodilator (afterload reduction), renal vasodilator and mild positive inotropic Read the complete document