Just to share some responses we have had, firstly from the EMA:
IMPAX labs have submitted an application for a Marketing authorization in EU in June 2014, but up to now the drug you are referring to has not been approved in the EU.
A very similar response was received from IMPAX, the company that makes this drug (although they refer to a later date, possibly something to do with the application being completed/reviewed/amended we cannot be sure):
On November 5, 2014, Impax submitted a Marketing Authorization Application to the European Medicines Agency (EMA). No further information is available at this time.
We were unable to get more information, we do know that the approval process can sometimes take a rather long time.
As soon as we have an update we will share it.
With very best wishes,
The Research Team