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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
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