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422 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: Tolvaptan Accord
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Sitagliptin / Metformin hydrochloride Sun
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
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Summary of opinion: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, 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: Lacosamide Adroiq
lacosamide, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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Summary of opinion: Sugammadex Adroiq
sugammadex, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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Summary of opinion: Dabigatran Etexilate Accord
dabigatran etexilate, opinion date: 30/03/2023, Positive, Last updated: 31/03/2023 -
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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): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion
Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020 -
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Direct healthcare professional communication (DHPC): Pazenir® (paclitaxel formulated as albumin bound nanoparticles) 5 mg/ml powder for dispersion for infusion: temporary supply shortage
Active substance: paclitaxel, DHPC type: Medicine shortage, Last updated: 25/01/2023 -
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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