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Regulatory Update - GSK and Valeant Receive Positive Opinion in Europe From the CHMP for Trobalt (Retigabine)

Fri, 01/21/2011 - 3:35am
Bio-Medicine.Org

MISSISSAUGA, Ontario, Jan. 21, 2011 /PRNewswire/ -- GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International, Inc. (NYSE & TSX: VRX) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Trobalt (retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalisation in adults aged 18 years and above with epilepsy.

Retigabine received a preliminary approval from the Swiss Agency for Therapeutic Products, Swissmedic, in December 2010.

Retigabine, referred to as ezogabine in the US, is being jointly developed by GSK and Valeant.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) - is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics.  More information about Valeant can be found at www.valeant.com.GlaxoSmithKline Enquiries:UK Media enquiries:

David Mawdsley

(020) 8047 5502Claire Brough

(020) 8047 5502Stephen Rea

(020) 8047 5502Alexandra Harrison

(020) 8047 5502US Media enquiries:

Nancy Pekarek

(919) 483 2839Mary Anne Rhyne

(919) 483 2839Kevin Colgan

(919) 483 2839Jennifer Armstrong

(919) 483 2839European Analyst/Investor enquiries:

Sally Ferguson

(020)

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