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Referral: Zinbryta
daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, EC decision date: 27/03/2018, Last updated: 11/07/2018 -
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Referral: Factor VIII
associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017 -
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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): 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 -
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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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Summary of opinion: Tecartus
opinion date: 15/10/2020, Positive, Last updated: 16/10/2020 -
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Summary of opinion: Onbevzi
bevacizumab, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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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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Summary of opinion: Xarelto
rivaroxaban, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization
Active substance: andexanet alfa, DHPC type: Adverse event, Last updated: 04/11/2020 -
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Summary of opinion: Elzonris
tagraxofusp, opinion date: 23/07/2020, Positive, Last updated: 13/11/2020 -
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Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)
Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020 -
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Summary of opinion: Kyprolis
carfilzomib, opinion date: 12/11/2020, Positive, Last updated: 13/11/2020 -
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Referral: Picato
ingenol mebutate, associated names: Picato, Article 20 procedures
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 06/07/2020, Last updated: 16/11/2020 -
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Referral: SGLT2 inhibitors
canagliflozin, dapagliflozin,empagliflozin, associated names: Edistride, Ebymect, Xigduo, Vokanamet, Synjardy, Jardiance, Invokana, Forxiga, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/02/2016, EC decision date: 28/04/2016, Last updated: 18/05/2016 -
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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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Summary of opinion: Bavencio
avelumab, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Doptelet
avatrombopag, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Spravato
esketamine, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Lumoxiti
moxetumomab pasudotox, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Kixelle
insulin aspart, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Yuflyma
adalimumab, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Inrebic
fedratinib, opinion date: 10/12/2020, Positive, Last updated: 11/12/2020 -
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Summary of opinion: Tecentriq
atezolizumab, opinion date: 17/09/2020, Positive, Last updated: 18/09/2020 -
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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