🇪🇺 APOKYN in European Union

EMA authorised APOKYN on 28 May 2001

Marketing authorisations

Application: EMEA/H/C/000327
Marketing authorisation holder: Abbott Laboratories Ltd.
Local brand name: Uprima
Indication: Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Uprima to be effective, sexual stimulation is required.
Status: withdrawn

Application: EMEA/H/C/000328
Marketing authorisation holder: Takeda Europe R Centre Ltd.
Local brand name: Ixense
Indication: Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Ixense to be effective, sexual stimulation is required.
Status: withdrawn

Application: EMEA/H/C/000386
Marketing authorisation holder: Abbott S.r.l.
Local brand name: Taluvian
Indication: Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Taluvian to be effective, sexual stimulation is required.
Status: withdrawn

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

Is APOKYN approved in European Union?

Yes. EMA authorised it on 28 May 2001; EMA authorised it on 28 May 2001; EMA authorised it on 28 May 2001.

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

Abbott Laboratories Ltd. holds the EU marketing authorisation.