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148 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: Trelegy Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, 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: Elebrato Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Abiraterone Krka
abiraterone acetate, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Celsunax
ioflupane (123I), opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Tagrisso
osimertinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Koselugo
selumetinib, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Maviret
glecaprevir, pibrentasvir, opinion date: 22/04/2021, Positive, Last updated: 26/04/2021 -
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Summary of opinion: Libtayo
cemiplimab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Darzalex
daratumumab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Spherox
spheroids of human autologous matrix-associated chondrocytes, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Icatibant Accord
opinion date: 20/05/2021, Positive, Last updated: 20/05/2021 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
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Summary of opinion: Keytruda
pembrolizumab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Benlysta
belimumab, opinion date: 25/03/2021, Positive, Last updated: 26/03/2021 -
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Summary of opinion: Venclyxto
venetoclax, opinion date: 22/04/2021, Positive, Last updated: 23/04/2021 -
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Summary of opinion: Blincyto
blinatumomab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Direct healthcare professional communication (DHPC): Tecentriq (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)
Active substance: atezolizumab, DHPC type: Adverse event, Last updated: 25/03/2021 -
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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): 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): 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): 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 -
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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