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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