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News: Registration opens for FDA/EMA orphan product designation and grant workshop
COMP, Last updated: 01/01/2015website (LINK). Registration is limited to 240 participants for the … -
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News: Registration opens for joint EMA/FDA/MHLW-PMDA orphan medicinal product workshop
COMP, Last updated: 19/12/2013sessions. Registration is limited to 150 participants for the … -
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News: Is an orphan medicine still an orphan once it gets on the market?
COMP, Last updated: 17/01/2018Sponsor: Merck Sharp & Dohme Limited Note Assessment report … details: Merck Sharp & Dohme Limited Hertford Road Hoddesdon … to Merck Sharp & Dohme Limited – EC decision of 15 March … -
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News: Committee for Orphan Medicinal Products elects new chair and vice-chair
COMP, Last updated: 13/09/2012injury, Tarix Pharmaceuticals Limited. • Mavoglurant for treatment … syndrome, Novartis Europharm Limited. • Rucaparib for treatment … cancer, Clovis Oncology UK Limited. 2. Opinions adopted at … -
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News: Committee for Orphan Medicinal Products (COMP) May 2012 highlights
COMP, Last updated: 22/05/2012disease, Emmaus Medical Europe Limited. • Recombinant human interleukin-7 … Laboratories (Maidenhead) Limited. • Talarozole for treatment … Laboratories (Maidenhead) Limited. • Talarozole for treatment … -
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News: Committee for Orphan Medicinal Products (COMP) June 2012 highlights
COMP, Last updated: 18/06/2012syndrome, Aptiv Solutions (UK) Limited. • Metreleptin for treatment … syndrome, Aptiv Solutions (UK) Limited. • Metreleptin for treatment … lipodystrophy, Aptiv Solutions (UK) Limited. • Metreleptin for treatment … -
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News: Committee for Orphan Medicinal Products (COMP) January 2012 highlights
COMP, Last updated: 16/01/2012ICON Clinical Research UK Limited. Committee for Orphan … hyperinsulinism, Biodel UK Limited. Heterologous human adult … Staphylococcus aureus, Envestia Limited. Ketoconazole for treatment … -
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News: Committee for Orphan Medicinal Products (COMP) December highlights
COMP, Last updated: 13/12/2011Catalent Pharma Solutions Limited. Nimorazole maleate … Pharmaceuticals (U.K.) Limited EU/3/08/556 Treatment of … -
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Press release: Committee for Orphan Medicinal Products - September 2007 Meeting
COMP, Last updated: 12/09/2007Everolimus from Novartis Europharm Limited, for treatment of gastro-entero-pancreatic … Lenalidomide from Celgene Europe Limited, for treatment of chronic … GlaxoSmithKline Research & Development Limited Orphan Indication Treatment … -
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Press release: Committee for Orphan Medicinal Products: May 2008 meeting
COMP, Last updated: 16/05/2007Rilonacept, Regeneron UK Limited, for treatment of cryopirin-associated … Sponsor Novartis Europharm Limited Orphan Indication Treatment … -
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Press release: 21st meeting of the Committee for Orphan Medicinal Products
COMP, Last updated: 27/02/20022-chloro-9-[2-deoxy-2-fluoro-ß-D-arabinofuranosyl]adenine Sponsor ILEX Services Limited Orphan Indication Treatment … Sponsor Ark Therapeutics Limited Orphan Indication Treatment … Azacitidine Sponsor Pharmion Limited Orphan Indication Treatment … -
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Press release: 18th meeting of the Committee for Orphan Medicinal Products
COMP, Last updated: 22/11/2001Sponsor Novartis Europharm Limited Orphan Indication Treatment … Sponsor Kendle International Limited Orphan Indication Treatment … Thalidomide Sponsor Pharmion Limited Orphan Indication Treatment … -
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Press release: Committee for Orphan Medicinal Products adopts 100th positive opinion on designation
COMP, Last updated: 26/03/2002Sponsor Novartis Europharm Limited Orphan Indication Treatment … Sponsor Novartis Europharm Limited Orphan Indication Treatment … -
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Press release: 11th meeting of the Committee for Orphan Medicinal Products
COMP, Last updated: 28/03/2001mesylate Sponsor Novartis Europharm Limited Orphan Indication Treatment … N-acetylgalactosamine-4-sulfatase Sponsor ClinTrials Research Limited Orphan Indication Treatment … -
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Press release: 9th meeting of the Committee for Orphan Medicinal Products
COMP, Last updated: 18/01/2001respond within a 3-month time limit. If no response from the sponsor … -
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Press release: 29th meeting of the Committee for Orphan Medicinal Products
COMP, Last updated: 22/11/2002IgM Sponsor SangStat UK Limited Orphan Indication Treatment … -
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Press release: 19th meeting of the Committee for Orphan Medicinal Products
COMP, Last updated: 19/12/2001Ligand Pharmaceuticals UK Limited Orphan Indication Treatment … -
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Press release: 16th meeting of the Committee for Orphan Medicinal Products
COMP, Last updated: 13/09/2001salt Sponsor Quintiles Limited Orphan Indication Treatment … -
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Press release: 14th meeting of the Committee for Orphan Medicinal Products
COMP, Last updated: 13/06/2001Cambridge Antibody Technology Limited Orphan Indication Prevention … -
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Press release: First EMEA workshop with industry on Orphan Medicinal Products
COMP, Last updated: 25/04/2001DÖRR ICN Pharmaceuticals Limited Dr Peter F HEINZEL Euro Nippon … -
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Press release: Inaugural meeting of the Committee for Orphan Medicinal Products
COMP, Last updated: 19/04/2000soft tissue sarcoma of the limbs 1,250 13 April 1999 Cerezyme …