Tanabe — Onerji EMA EPAR public assessment report (EMEA/H/C/006429, 2026)
Tanabe · 2026 · EMA EPAR public assessment report
Report summary
The EMA's CHMP issued a positive opinion for Onerji (levodopa/carbidopa) for advanced Parkinson's disease, citing a favorable benefit-risk balance. Onerji, a continuous subcutaneous infusion, demonstrated significant improvements in "ON" time and reduced "OFF" time compared to oral levodopa/carbidopa in clinical trials. While effective, the treatment is associated with a high incidence of reversible infusion site reactions, primarily due to L-arginine, and a potential for vitamin B6 deficiency. Risk minimization measures, including an educational program, are planned. The product's quality, stability, and compatibility with delivery systems were confirmed, and non-clinical data supported its safety profile.
Key findings — cited to the page
| Package size | 30 vials | · p.13 |
| Route of administration | Subcutaneous use | · p.13 |
| Product name | Onerji | · p.13 |
| Strength (carbidopa) | 7.5 mg/ml | · p.13 |
| Applicant | Tanabe Pharma GmbH | · p.13 |
| Strength (levodopa) | 60 mg/ml | · p.13 |
| EMA Product Number | EMEA/H/C/006429 | · p.13 |
| Active substance | levodopa / carbidopa | · p.13 |
| Patients exposed (ND0612/002) | 8 | ND0612/002 · p.143 |
| ATC code | N04BA02 | · p.13 |
| Pharmaceutical form | Solution for infusion | · p.13 |
| Orphan designation | No | · p.13 |
Source: Tanabe ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →