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91 results
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Summary of opinion: Sondelbay
teriparatide, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
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Summary of opinion: Vildagliptin / Metformin hydrochloride Accord
vildagliptin / metformin hydrochloride, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
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Summary of opinion: Amversio
betaine anhydrous, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Sitagliptin Accord
sitagliptin, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Carvykti
ciltacabtagene autoleucel, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
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Summary of opinion: Cabometyx
cabozantinib, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
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Summary of opinion: Polivy
polatuzumab vedotin, opinion date: 24/03/2022, Positive, Last updated: 25/03/2022 -
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Summary of opinion: Lunsumio
mosunetuzumab, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Pirfenidone AET
pirfenidone, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Retsevmo
selpercatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Kinpeygo (new)
budesonide, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Nexpovio (new)
selinexor, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Zokinvy (new)
lonafarnib, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Upstaza (new)
eladocagene exuparvovec, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Ertapenem SUN (new)
ertapenem, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Tuznue (new)
trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 20/05/2022 -
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Summary of opinion: Hervelous (new)
trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 20/05/2022 -
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Summary of opinion: Sugammadex Fresenius Kabi (new)
sugammadex, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Accord (new)
sitagliptin, metformin hydrochloride, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Summary of opinion: Ganirelix Gedeon Richter (new)
ganirelix, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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Orphan designation: N-(2,4-di-tert-butyl-5-hydroxyphenyl)-1,4-dihydro-4-oxoquinoline-3-carboxamide (ivacaftor) for: Treatment of cystic fibrosis
Date of designation: 08/07/2008, Positive, Last updated: 25/01/2022 -
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Orphan designation: Carboxypeptidase G2 (glucarpidase) for: Adjunctive treatment in patients at risk of methotrexate toxicity
Date of designation: 03/02/2003, Positive, Last updated: 20/01/2022 -
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Orphan designation: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains (idecabtagene vicleucel) for: Treatment of multiple myeloma
Date of designation: 20/04/2017, Positive, Last updated: 03/12/2021 -
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Orphan designation: velaglucerase alfa for: Treatment of Gaucher disease
Date of designation: 06/06/2010, Positive, Last updated: 24/09/2021 -
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Orphan designation: Recombinant human parathyroid hormone for: Treatment of hypoparathyroidism
Date of designation: 16/01/2014, Positive, Last updated: 24/09/2021