Onerji (levodopa;carbidopa)

Region: 🇪🇺 EU
Active substance: levodopa;carbidopa
Company: Tanabe Pharma GmbH
Status: Authorised
Therapeutic area: Parkinson Disease
CHMP opinion: Thu 26 Feb 2026
EU approval: Mon 27 Apr 2026
Application: EMEA/H/C/006429
ATC: N04BA02
Official record: www.ema.europa.eu

Indication

Onerji is indicated for the treatment of motor fluctuations in patients with advanced Parkinson's disease which are not sufficiently controlled by oral anti-Parkinson medicinal products.

Regulatory milestones

Mon 27 Apr 2026🇪🇺 EU approval (EC decision)

Onerji (levodopa;carbidopa) approved in the EU

Marketing authorisation to Tanabe Pharma GmbH · source

Thu 26 Feb 2026🇪🇺 CHMP positive opinion

Onerji (levodopa;carbidopa): CHMP positive opinion

Tanabe Pharma GmbH · source

Same substance in other markets

🇪🇺 Hopledo Authorised · Zambon SpA
🇪🇺 Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) Authorised · Orion Corporation
🇪🇺 Levodopa/Carbidopa/Entacapone Orion Authorised · Orion Corporation
🇪🇺 Stalevo Authorised · Orion Corporation
🇪🇺 Numient Withdrawn · Amneal Pharma Europe Ltd

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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.