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136 results
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Summary of opinion: Pemazyre (updated)
pemigatinib, opinion date: 28/01/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Retsevmo
selpercatinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Sunitinib Accord
sunitinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Thiotepa Riemser
thiotepa, 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: Keytruda
pembrolizumab, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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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: Tysabri
natalizumab, opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Vaxchora
Cholera vaccine (recombinant, live, oral), opinion date: 28/01/2021, Positive, Last updated: 01/02/2021 -
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Summary of opinion: Cabometyx
cabozantinib, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Temybric Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Abiraterone Accord
abiraterone, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Quofenix
delafloxacin, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Elebrato Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Jemperli
dostarlimab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Sarclisa
isatuximab, opinion date: 25/02/2021, Positive, Last updated: 26/02/2021 -
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Summary of opinion: Trelegy Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Direct healthcare professional communication (DHPC): Picato (ingenol mebutate) – Suspension of the marketing authorisation due to risk of skin malignancy
Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020 -
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Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity
Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020 -
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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): 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): 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): Systemic and inhaled fluoroquinolones: risk of heart valve regurgitation/incompetence
Active substance: Delafloxacin, levofloxacin, DHPC type: Safety signal, Last updated: 29/10/2020 -
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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): Gilenya (fingolimod) - Updated recommendations to minimise the risk of drug-induced liver injury (DILI)
Active substance: Fingolimod, DHPC type: Periodic safety update report, Last updated: 10/11/2020