Tuesday 25 November, 2008

Pramipexole Dihydrochloride(Mirapexin): Synthon successfully completes European decentralized procedures for generic version

Generic player Synthon announced (in a press release here) that it has successfully completed multiple decentralized procedures (DCP) for Pramipexole tablets. The Regulatory clearance has been obtained by Synthon in thirteen European countries. Synthon will market Pramipexole through its marketing partners in the following five strengths: 0.125 mg; 0.25 mg; 0.5 mg; 1.0 mg and 1.5 mg of Pramipexole dihydrochloride tablets.
Synthon is currently licensing out this product in Europe. The company has several free marketing authorizations available for new marketing partners. Pramipexole (known in Europe under the trade names Sifrol® and Mirapexin® and in the U.S.A. as Mirapex®), is a compound from Boehringer Ingelheim research first licensed in 1997 for the treatment of the signs and symptoms of idiopathic Parkinson`s Disease, as monotherapy or in combination with levodopa. In Europe, sales of Pramipexole were € 321 million in 2007 with a 29% annual growth (IMS Midas data).
Earlier news of IPPharmadoc on Pramipexole Here


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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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