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Referral: Zinbryta
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: Zinbryta
daclizumab, associated names: Zinbryta, Article 20 procedures
Status: European Commission final decision, opinion/position date: 09/11/2017, EC decision date: 08/01/2018, Last updated: 12/01/2018 -
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Referral: Lartruvo
olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019 -
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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: Xofigo
radium Ra223 dichloride, associated names: Xofigo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 26/07/2018, EC decision date: 28/09/2018, Last updated: 11/10/2018 -
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Referral: Quinolone- and fluoroquinolone-containing medicinal products
nalidixic acid, pipemidic acid, cinoxacin, enoxacin, pefloxacin, lomefloxacin, ciprofloxacin, levofloxacin, ofloxacin, moxifloxacin, norfloxacin, prulifloxacin, rufloxacin, flumequin, associated names: Quinsair, Article 31 referrals
Status: European Commission final decision, opinion/position date: 15/11/2018, EC decision date: 11/03/2019, Last updated: 08/06/2023 -
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Referral: Rubraca
rucaparib, associated names: Rubraca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2022, EC decision date: 21/09/2022, Last updated: 17/10/2022 -
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Referral: Zydelig
idelalisib, associated names: Zydelig, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2016, EC decision date: 15/09/2016, Last updated: 03/10/2016 -
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Summary of opinion: Albrioza
sodium phenylbutyrate, Ursodoxicoltaurine, opinion date: 22/06/2023, Negative, Last updated: 06/07/2023 -
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Referral: Lemtrada
alemtuzumab, associated names: Lemtrada, Article 20 procedures
Status: European Commission final decision, opinion/position date: 14/11/2019, EC decision date: 16/01/2020, Last updated: 04/02/2020 -
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Summary of opinion: Inaqovi
cedazuridine, decitabine, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Bylvay
odevixibat, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Tepkinly
epcoritamab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Tevimbra
tislelizumab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Degarelix Accord
degarelix acetate, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Referral: Zynteglo
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 22/07/2021, EC decision date: 16/09/2021, Last updated: 08/07/2022 -
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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: Refixia
nonacog beta pegol, opinion date: 22/06/2023, Positive, Last updated: 23/06/2023 -
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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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Summary of opinion: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products
capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020 -
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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: Camzyos
mavacamten, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Referral: Adakveo
crizanlizumab, associated names: Adakveo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 25/05/2023, EC decision date: 03/08/2023, Last updated: 29/08/2023 -
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Summary of opinion: Adcetris (new)
brentuximab vedotin, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023