Human medicines European public assessment report (EPAR): Onerji, levodopa,carbidopa, Status: Opinion

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Source: EMA New Medicines

Original: https://www.ema.europa.eu/en/medicines/human/EPAR/onerji...

Published: Fri, 27 Feb 2026 12:00:00 +0100

Onerji is a medicine containing levodopa, carbidopa and entacapone, intended for the treatment of Parkinson's disease.[2] Levodopa is converted in the brain to dopamine, which restores its levels in the parts of the brain that control movement and coordination.[2] Carbidopa blocks the dopadecarboxylase enzyme and entacapone blocks the COMT enzyme, preventing the breakdown of levodopa in the body and prolonging its effect.[1][2] This mechanism relieves symptoms such as muscle stiffness.[1] The company conducted bioequivalence studies that demonstrated the same blood levels of levodopa, carbidopa and entacapone as the reference drug.[1][2] The maximum daily dose is 10 tablets, with the exception of tablets with 175 mg levodopa/43.75 mg carbidopa (max. 8 tablets) and 200 mg levodopa/50 mg carbidopa (max. 7 tablets).[1][2] The CHMP decided that the benefits of the drug outweigh the risks.[2]