🇪🇺 Spectrila® in European Union

EMA authorised Spectrila® on 14 January 2016

Marketing authorisation

EMA — authorised 14 January 2016

• Application: EMEA/H/C/002661
• Marketing authorisation holder: Medac Gesellschaft fuer klinische Spezialpraeparate mbH
• Local brand name: Spectrila
• Indication: Spectrila is indicated as a component of antineoplastic combination therapy for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years and adults.
• Status: approved

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Frequently asked questions

Is Spectrila® approved in European Union?

Yes. EMA authorised it on 14 January 2016.

Who is the marketing authorisation holder for Spectrila® in European Union?

Medac Gesellschaft fuer klinische Spezialpraeparate mbH holds the EU marketing authorisation.