Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 23 August 2018

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Category Value
Agency product number EMEA/H/C/004062
Orphan designation No
Date First Approved 19-11-2015
Type Medicinal product subject to medical prescription
Marketing authorisation holder Novartis Europharm Limited
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