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37 results
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Summary of opinion: Nexviadyme
Avalglucosidase alfa, opinion date: 23/07/2021, Positive, Last updated: 02/08/2021 -
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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: Dimethyl fumarate Polpharma
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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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: Dimethyl fumarate Neuraxpharm
dimethyl fumarate, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
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Summary of opinion: Dimethyl fumarate Mylan
dimethyl fumarate, 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: Kymriah
tisagenlecleucel, 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: Amifampridine SERB
amifampridine, 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 (new)
mosunetuzumab, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Yescarta (new)
axicabtagene ciloleucel, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Pirfenidone AET (new)
pirfenidone, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Retsevmo (new)
selpercatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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Summary of opinion: Filsuvez (new)
birch bark extract, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
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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): 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): 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): 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): 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): 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): 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