Tuesday, November 27, 2012

Marvel LifeSciences Ltd withdraws its marketing authorisation applications for Solumarv, Isomarv and Combimarv (human insulin)

The European Medicines Agency has been formally notified by Marvel LifeScience Ltd of its decision to withdraw its applications for centralised marketing authorisations for the medicines Solumarv, Isomarv and Combimarv (human insulin), all 100 IU/ml solution for injection. They were intended to be used for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.

In its official letter, Marvel Lifescience stated that, “the decision to withdraw is in order to have sufficient time to repeat and submit bioequivalence T1D [type 1 diabetes] PK/PD [pharmacokinetic/pharmacodynamic] data on each clamp study in order to comply with the planned new insulin guidelin

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