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Indivior Announces Validation of Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for SUBOXONE®(buprenorphine and naloxone) Sublingual Film

Slough, UK, 18 June 2019–Indivior PLC (LON: INDV) (the ‘Company’), a global specialty pharmaceutical company with a 20-year legacy of leadershipin developing medicines to treatopioid use disorder (OUD),today announced that the European Medicines Agency (EMA) has completed formal validation of Indivior’s Marketing Authorization Application (MAA) for SUBOXONE Film. Validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

http://www.indivior.com/wp-content/uploads/2019/06/EMEA-Suboxone-Film-Validation-approval-press-release_Final.pdf