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Tag: chmp
CHMP Issues Positive Opinion for Intravenous (IV) Formulation of Mercks NOXAFIL (posaconazole)
2014-07-30 14:00:03| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. WHITEHOUSE STATION, N.J., July 30, 2014 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of a new, investigational intravenous (IV) formulation of NOXAFIL (posaconazole). Language: English read more
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CHMP Recommends EU Approval Of VIZAMYL (Flutemetamol F18 Injection) For PET Imaging Of Beta Amyloid Plaque
2014-07-02 10:35:13| drugdiscoveryonline Home Page
GE Healthcare recently announced the receipt of a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)
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PTC Therapeutics Receives Positive Opinion From CHMP For Translarna (ataluren)
2014-06-04 13:02:23| drugdiscoveryonline News Articles
PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that following its request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the company's application for a conditional marketing authorization of TranslarnaTM (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients aged five years and older
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Merck and Endocyte Announce European CHMP Positive Opinions for VYNFINIT (vintafolide) and Companion Imaging Agents FOLCEPRI (etarfolatide) and NEOCEPRI (Intravenous (IV) folic acid) in Patients with Platinum-Resistant ...
2014-03-21 13:05:00| Merck.com - Research & Development News
Dateline City: WHITEHOUSE STATION, N.J. & WEST LAFAYETTE, Ind. WHITEHOUSE STATION, N.J. & WEST LAFAYETTE, Ind.--(BUSINESS WIRE)-- Merck and Endocyte Announce European CHMP Positive Opinions for VYNFINIT (vintafolide) and Companion Imaging Agents FOLCEPRI (etarfolatide) and NEOCEPRI (Intravenous (IV) folic acid) in Patients with Platinum-Resistant Ovarian Cancer Language: English Contact: MerckMedia:Ian McConnell, +1 908-423-3046Claire Mulhearn, +1 908-423-7425orInvestors:Carol Ferguson, +1 908-423-4465Justin Holko, +1 908-423-5088orEndocyteMedia:Martina Schwarzkopf, +1 212-845-4292Tony Russo, +1 212-845-4251orInvestors:Stephanie Ascher, +1 212-362-1200 Ticker Slug: Ticker: MRK Exchange: NYSE Ticker: ECYT Exchange: NASDAQ read more
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CHMP Issues Positive Opinion for Tablet Formulation of Merck's NOXAFIL
2014-03-01 00:42:42| Biotech - Topix.net
Merck , known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
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