EMA: Novartis Europharm Withdrew Extension For Exelon, Prometax
March 15 2012 - 11:48AM
Dow Jones News
The European Medicines Agency, or EMA, Thursday said Novartis
Europharm Ltd withdrew its applications for an extension of the
indication for Exelon and Prometax, or rivastigmine.
MAIN FACTS:
-Novartis Europharm decided to withdraw its applications for an
extension of the therapeutic indication for the centrally
authorized medicines Exelon and Prometax 4.6 mg/24 h and 9.5 mg/24h
transdermal patches.
-Company decided to withdraw the application after the CHMP
indicated that in order to conclude a favorable approval additional
data was required, which could not be generated within the time
frame allowed in the centralized procedure.
-Both medicines continue to be authorized in the currently
approved indications.
-By Tapan Panchal, Dow Jones Newswires. Tel +44(0)207-842 9448,
tapan.panchal@dowjones.com
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