🇪🇺 Anti-Parkinson medication in European Union

EMA authorised Anti-Parkinson medication on 27 October 1997

Marketing authorisations

Application: EMEA/H/C/000135
Marketing authorisation holder: Dr. Karl Thomae GmbH
Local brand name: Daquiran
Indication: DAQUIRAN tablets are indicated for treatment of the signs and symptoms of advanced idiopathic Parkinson's disease in combination with levodopa, i.e. over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations).
Status: withdrawn

Application: EMEA/H/C/000134
Marketing authorisation holder: Boehringer Ingelheim International GmbH
Local brand name: Mirapexin
Indication: Mirapexin is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Mirapexin is indicated for symptomatic treatment of moderate to severe idiopathic restless-legs syndrome in dosages up to 0.54 mg of base (0.75 mg of salt).
Status: approved

Application: EMEA/H/C/000941
Marketing authorisation holder: Krka, d.d., Novo mesto
Local brand name: Oprymea
Indication: Oprymea is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or "on off" fluctuations). Oprymea is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Status: approved

Application: EMEA/H/C/000940
Marketing authorisation holder: Teva Pharma B.V.
Local brand name: Pramipexole Teva
Indication: Pramipexole Teva is indicated for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations). Pramipexole Teva is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Status: approved

Application: EMEA/H/C/002291
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Pramipexole Accord
Indication: Pramipexole Accord is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end-of-dose or 'on-off' fluctuations).
Status: withdrawn

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

Is Anti-Parkinson medication approved in European Union?

Yes. EMA authorised it on 27 October 1997; EMA authorised it on 23 February 1998; EMA authorised it on 12 September 2008.

Who is the marketing authorisation holder for Anti-Parkinson medication in European Union?

Dr. Karl Thomae GmbH holds the EU marketing authorisation.