Orion Corporation — Corbilta (previously Levodopa/Carbidopa/Entacapone Sandoz) EMA EPAR public assessment report (EMEA/H/C/002785, 2013)
Orion Corporation · 2013 · EMA EPAR public assessment report · company profile →
Report summary
Orion Corporation submitted a Marketing Authorisation Application for Levodopa/Carbidopa/Entacapone Sandoz (now Corbilta) on February 7, 2013, for treating adult Parkinson's disease patients experiencing end-of-dose motor fluctuations. Based on informed consent from the Stalevo marketing authorization, the CHMP issued a positive opinion on September 19, 2013. The CHMP also endorsed the Risk Management Plan, which outlined important identified and potential risks associated with the product.
Key findings — cited to the page
| Marketing Authorisation Application submission date | 7 February 2013 | Levodopa/Carbidopa/Entacapone Sandoz · EU · p.4 |
| CHMP positive opinion date | 19 September 2013 | Levodopa/Carbidopa/Entacapone Sandoz · EU · p.5 |
| Indication | treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment | Levodopa/Carbidopa/Entacapone Sandoz · EU · p.4 |
| Important identified risks | Rhabdomyolysis, NMS, Liver and biliary system disorders and liver laboratory abnormalities, Impulse control disorders, Depression with suicidal tendencies, Gastrointestinal haemorrhage, Colitis, Thrombocytopenia, Orthostatic hypotension, and Myocardial infarction and other ischaemic heart disease | Levodopa/Carbidopa/Entacapone Sandoz · p.13 |
| Important potential risks | Severe skin and severe allergic reactions, Prostate cancer, Medication Error | Levodopa/Carbidopa/Entacapone Sandoz · p.13 |
| Important missing information | Pregnancy | Levodopa/Carbidopa/Entacapone Sandoz · p.13 |
Source: Orion Corporation ↗ · 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 →