Orion CorporationORN

Orion Corporation (ORN) focuses on neurology. The company has developed Levodopa/Carbidopa/Entacapone Orion, which received a CHMP positive opinion on 23 June 2011 in Europe. This application, based on Article 10(c) of Directive 2001/83/EC, referenced Stalevo, which had a marketing authorisation date of 17 October 2003 in Europe. The procedure for Levodopa/Carbidopa/Entacapone Orion started on 24 April 2011, following an application submission on 7 April 2011.

Another product, Levodopa/Carbidopa/Entacapone Sandoz, received a CHMP positive opinion on 19 September 2013 in the European Union. This drug is indicated for the treatment of adult patients with Parkinson’s disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. Important identified risks for Levodopa/Carbidopa/Entacapone Sandoz include 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. Important potential risks include Severe skin and severe allergic reactions, Prostate cancer, and Medication Error, with important missing information regarding Pregnancy.