🇪🇺 Tacrolimus capsule in European Union

EMA authorised Tacrolimus capsule on 27 February 2002

Marketing authorisation

EMA — authorised 27 February 2002

  • Application: EMEA/H/C/000374
  • Marketing authorisation holder: LEO Pharma A/S
  • Local brand name: Protopic
  • Indication: Flare treatment Adults and adolescents (16 years of age and above) Treatment of moderate to severe atopic dermatitis in adults who are not adequately responsive to or are intolerant of conventional therapies such as topical corticosteroids. Children (two years of age and above) Treatment of moderate to severe atopic dermatitis in children (two years of age and above) who failed to respond adequately to conventional therapies such as topical corticosteroids. Maintenance treatment Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of f
  • Status: approved

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Other Immunology approved in European Union

Frequently asked questions

Is Tacrolimus capsule approved in European Union?

Yes. EMA authorised it on 27 February 2002.

Who is the marketing authorisation holder for Tacrolimus capsule in European Union?

LEO Pharma A/S holds the EU marketing authorisation.