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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: Nexpovio
selinexor, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Koselugo (new)
selumetinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Enspryng (new)
satralizumab, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Kalydeco
ivacaftor, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
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Referral: Lartruvo
olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019 -
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Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa
Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020 -
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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): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization
Active substance: andexanet alfa, DHPC type: Adverse event, Last updated: 04/11/2020 -
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Referral: Zynteglo
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: Procedure started, Last updated: 12/03/2021 -
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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): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders
Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021 -
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Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia (new)
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021 -
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Direct healthcare professional communication (DHPC): COVID-19 Vaccine Janssen: link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia (new)
Active substance: adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S), DHPC type: Safety signal, Last updated: 26/04/2021