Oprymea (pramipexole)
- Region
- 🇪🇺 EU
- Active substance
- pramipexole
- Company
- KRKA tovarna zdravil d.d. Novo mesto
- Status
- Authorised
- Therapeutic area
- Parkinson Disease
- EU approval
- Fri 12 Sep 2008
- Designations
- Generic
- Application
- EMEA/H/C/000941
- ATC
- N04BC05
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Mirapexin Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Sifrol Authorised · Boehringer Ingelheim International GmbH
- 🇪🇺 Pramipexole Teva Authorised · Teva Pharma B.V.
- 🇪🇺 Pramipexole Accord Withdrawn · Accord Healthcare S.L.U.
- 🇪🇺 Daquiran Withdrawn · Dr. Karl Thomae GmbH
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