🇪🇺 prabotulinumtoxinA in European Union

EMA authorised prabotulinumtoxinA on 27 September 2019

Marketing authorisation

EMA — authorised 27 September 2019

  • Application: EMEA/H/C/004587
  • Marketing authorisation holder: Evolus Pharma B.V.
  • Local brand name: Nuceiva
  • Indication: Temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.
  • Status: approved

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Frequently asked questions

Is prabotulinumtoxinA approved in European Union?

Yes. EMA authorised it on 27 September 2019.

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

Evolus Pharma B.V. holds the EU marketing authorisation.