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EMEA approval of Tasigna expected by November 2007
On 20 September 2007 the CHMP
(Committee for Medicinal Products for Human Use)
of the EMEA
(European Medicines Evaluation Agency) adopted a positive opinion towards Tasigna and recommended to grant a marketing authorisation for the drug at 200 mg, hard capsule for CML with intolerance or resistance against Gleevec.
This recommendation has to be adopted by the EU commission, which usually agrees to suggestions by CHMP within 3 months.
Hence we can expect the approval of Tasigna by EMEA by November this year.
Read the EMEA press release