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17 results
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Summary of opinion: Sirturo
bedaquiline, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Abevmy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Lextemy
bevacizumab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Evkeeza
evinacumab, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Koselugo
selumetinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Enspryng
satralizumab, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Darzalex (new)
daratumumab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Bylvay (new)
odevixibat, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Imcivree (new)
setmelanotide, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
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Summary of opinion: Blincyto (new)
blinatumomab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet
Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020 -
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Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Active substance: Letermovir, Last updated: 11/09/2020 -
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Direct healthcare professional communication (DHPC): Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy
Active substance: Lomitapide, DHPC type: Post-authorisation measure, Last updated: 17/02/2021 -
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Direct healthcare professional communication (DHPC): Strimvelis® (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] cDNA sequence): first case of lymphoid T cell leukaemia after insertional oncogenesis
Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, DHPC type: Adverse event, Last updated: 22/03/2021 -
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Direct healthcare professional communication (DHPC): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy
Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021 -
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Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin) 140 mg powder for concentrate for solution for injection: Important information on plastic vial flip-off cap colour
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020