🇪🇺 Aripiprazole Once-Monthly in European Union

EMA authorised Aripiprazole Once-Monthly on 14 November 2013

Marketing authorisation

EMA — authorised 14 November 2013

  • Application: EMEA/H/C/002755
  • Marketing authorisation holder: Otsuka Pharmaceutical Netherlands B.V.
  • Local brand name: Abilify Maintena
  • Indication: Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
  • Status: approved

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Aripiprazole Once-Monthly in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Aripiprazole Once-Monthly approved in European Union?

Yes. EMA authorised it on 14 November 2013.

Who is the marketing authorisation holder for Aripiprazole Once-Monthly in European Union?

Otsuka Pharmaceutical Netherlands B.V. holds the EU marketing authorisation.