Pramipexole Accord (pramipexole)
- Region
- 🇪🇺 EU
- Active substance
- pramipexole
- Company
- Accord Healthcare S.L.U.
- Status
- Withdrawn
- Therapeutic area
- Parkinson Disease; Restless Legs Syndrome
- CHMP opinion
- Thu 21 Jul 2011
- EU approval
- Thu 29 Sep 2011
- Designations
- Generic
- Application
- EMEA/H/C/002291
- ATC
- N04BC05
- Official record
- www.ema.europa.eu
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).
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.
- 🇪🇺 Oprymea Authorised · KRKA tovarna zdravil d.d. Novo mesto
- 🇪🇺 Daquiran Withdrawn · Dr. Karl Thomae GmbH
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.