🇪🇺 Testosterone Undecanoate and/or PDE-5 in European Union

EMA authorised Testosterone Undecanoate and/or PDE-5 on 6 March 2003

Marketing authorisation

EMA — authorised 6 March 2003

  • Application: EMEA/H/C/000475
  • Marketing authorisation holder: Bayer AG
  • Local brand name: Levitra
  • Indication: Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Levitra to be effective, sexual stimulation is required. Levitra is not indicated for use by women.
  • Status: approved

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Testosterone Undecanoate and/or PDE-5 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 Testosterone Undecanoate and/or PDE-5 approved in European Union?

Yes. EMA authorised it on 6 March 2003.

Who is the marketing authorisation holder for Testosterone Undecanoate and/or PDE-5 in European Union?

Bayer AG holds the EU marketing authorisation.