Genmab — April 2016
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The Committee recommended granting a conditional marketing authorisation for Darzalex (daratumumab) for the treatment of relapsed and refractory multiple myeloma. Darzalex has an orphan designation and was reviewed under EMA’s accelerated assessment scheme. For more information, please see the press release in the grid below.
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2 A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit
to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The
marketing authorisation holder is likely to provide comprehensive clinical data at a later stage. -
Det er ok Bulder.
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Endelig godkendelse inden for 67 dage
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Det er da hurtigt.
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Lancering i juni eller juli i de første EU markeder
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Men ikke hurtigt nok for patienterne.
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Nordea har indregnet USD 67m i salg i 2016 til EU lande
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