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ZIMINO (levosimendan), cardiac stimulant
CARDIOLOGY - New medicinal product
Opinions on drugs -
Posted on
Jun 29 2016
Reason for request
Inclusion
Low clinical benefit in the short-term treatment of acute decompensated severe chronic heart failure reserved as a last resort in adults in an emergency situation, especially in cases of refractory cardiac decompensation who failed weaning from inotropes or circulatory support.
- ZIMINO, Euro generic of SIMDAX, has marketing authorisation in the short-term treatment of acutely decompensated severe chronic heart failure (ADHF) in situations where conventional therapy is not sufficient, and in cases where inotropic support is considered appropriate in adults.
- The available clinical data do not justify its efficacy in the marketing authorisation indication.
- However its use under its temporary authorisation for use by a named person since 2004 confirms a substantial therapeutic need. Only a few results with a very low level of evidence appear to show its benefit.
Clinical Benefit
| Low |
- |
Clinical Added Value
| no clinical added value |
- |
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