Extended storage for COPAXONE pre-filled syringe

Published: 6-Jun-2007
Regulatory

The application for up to one-month ambient temperature storage of COPAXONE (glatiramer acetate injection) pre-filled syringe has been approved by the US FDA and in Europe under the Mutual Recognition Procedure (MRP).


The application for up to one-month ambient temperature storage of COPAXONE (glatiramer acetate injection) pre-filled syringe has been approved by the US FDA and in Europe under the Mutual Recognition Procedure (MRP).

Prior to this approval, COPAXONE was approved for storage at room temperature for up to seven days.

Marketed by Teva Pharmaceutical Industries and sanofi-aventis, COPAXONE is indicated for the reduction of the frequency of relapses in ambulatory patients with RRMS characterised by at least two attacks of neurological dysfunction over the preceding two-year period. It is approved in 47 countries worldwide, including the US, Canada, Mexico, Australia, Israel, and all European countries.

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