Orion Corporation — Levodopa/Carbidopa/Entacapone Orion EMA EPAR public assessment report (EMEA/H/C/002441, 2011)
Orion Corporation · 2011 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) assessed Levodopa/Carbidopa/Entacapone Orion, an informed consent application referencing the authorized product Stalevo. The Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for treating adult Parkinson's disease patients experiencing end-of-dose motor fluctuations. The quality, safety, and efficacy of Levodopa/Carbidopa/Entacapone Orion were deemed identical to Stalevo.
Key findings — cited to the page
| Reference product marketing authorisation date | 17 October 2003 | Stalevo · Europe · p.5 |
| Procedure start date | 24 April 2011 | Levodopa/Carbidopa/Entacapone Orion · Europe · p.5 |
| CHMP positive opinion date | 23 June 2011 | Levodopa/Carbidopa/Entacapone Orion · Europe · p.5 |
| CHMP opinion on Stalevo PL readability testing | 25 September 2008 | Stalevo · Europe · p.6 |
| Application submission date | 7 April 2011 | Levodopa/Carbidopa/Entacapone Orion · Europe · p.4 |
| Eligibility to centralised procedure agreed date | 26 October 2010 | Levodopa/Carbidopa/Entacapone Orion · Europe · p.4 |
| Legal basis for application | Article 10(c) of Directive 2001/83/EC – informed consent application | Levodopa/Carbidopa/Entacapone Orion · Europe · p.4 |
| Reference product marketing authorisation date | 17 October 2003 | Stalevo · Europe · p.4 |
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 →