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28 results
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Summary of opinion: Sohonos (updated)
palovarotene, opinion date: 26/01/2023, Negative, Last updated: 26/05/2023 -
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Summary of opinion: Tidhesco
ivosidenib, opinion date: 23/02/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Omblastys
iodine (131I) omburtamab, opinion date: 15/12/2022, Negative, Last updated: 16/12/2022 -
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Summary of opinion: Hyftor
sirolimus, opinion date: 23/02/2023, Positive, Last updated: 24/02/2023 -
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Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
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Summary of opinion: Fintepla
fenfluramine, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
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Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Lytgobi
futibatinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Jaypirca
pirtobrutinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Columvi
glofitamab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Sogroya (new)
somapacitan, opinion date: 26/05/2023, Positive, Last updated: 26/05/2023 -
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Summary of opinion: Ztalmy (new)
ganaxolone, opinion date: 26/05/2023, Positive, Last updated: 26/05/2023 -
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Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone): Discontinuation of manufacturing at the end of 2024 and update on 100mcg shortage
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 04/10/2022 -
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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): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)
Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022 -
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Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone) 100 micrograms/dose powder and solvent for solution for injection: expected shortage from June 30th, 2022
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 29/04/2022 -
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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): Caprelsa (vandetanib): Restriction of indication
Active substance: Vandetanib, DHPC type: Restriction of indication, Last updated: 28/02/2023 -
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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): Myalepta (metreleptin) 5.8 mg vial: shortage and mitigation plan
Active substance: Metreleptin, DHPC type: Medicine shortage, Last updated: 14/03/2023 -
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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 -
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Direct healthcare professional communication (DHPC): Adakveo (crizanlizumab): Phase III study (CSEG101A2301) shows no superiority of crizanlizumab over placebo
Active substance: Crizanlizumab, DHPC type: Referral - Article 20 procedure, Last updated: 14/02/2023 -
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Direct healthcare professional communication (DHPC): Ocaliva (obeticholic acid): New contraindication for the treatment of primary biliary cholangitis (PBC) in patients with decompensated liver cirrhosis or a history of prior hepatic decompensation
Active substance: Obeticholic acid, DHPC type: New contraindication, Last updated: 09/06/2022 -
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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): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy
Active substance: Onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021