NeLM news service
Marketing authorisation application in EU for Topotecan SUN (topotecan) withdrawn

Source: EMA

Date published: 18/02/2011 16:46

Summary
by: Yuet Wan

The European Medicines Agency (EMA) has been formally notified by Sun Pharmaceutical Industries B.V. of its decision to withdraw its application for a centralised marketing authorisation for Topotecan SUN (topotecan) 1 mg and 4 mg powder for concentrate for solution for infusion. The medicine was developed as a generic medicine to be used for the treatment of metastatic cancer of the ovary, small cell lung cancer and cervical cancer. In its official letter, the company stated that it decided to discontinue the application due to the number of competitors.

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