🇪🇺 Vivarin in European Union

EMA authorised Vivarin on 24 March 2017

Marketing authorisations

EMA — authorised 24 March 2017

  • Application: EMEA/H/C/004100
  • Marketing authorisation holder: Viridian Pharma Ltd
  • Local brand name: Blectifor
  • Indication: Indicated in preterm neonates for the prevention of bronchopulmonary dysplasia
  • Pathway: orphan
  • Status: withdrawn

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EMA — authorised 19 August 2020

  • Application: EMEA/H/C/005435
  • Marketing authorisation holder: Gennisium Pharma
  • Local brand name: Gencebok
  • Indication: Treatment of primary apnoea of premature newborns.
  • Status: approved

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Vivarin in other countries

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

Other Other approved in European Union

Frequently asked questions

Is Vivarin approved in European Union?

Yes. EMA authorised it on 24 March 2017; EMA authorised it on 19 August 2020.

Who is the marketing authorisation holder for Vivarin in European Union?

Viridian Pharma Ltd holds the EU marketing authorisation.