Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 09 August 2018

Indication(s)

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Category Value
Agency product number EMEA/H/C/002569
Orphan designation No
Date First Approved 21-11-2014
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Boehringer Ingelheim International GmbH
Warnings This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions