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36 results
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Summary of opinion: Meloxoral
meloxicam, opinion date: 06/10/2022, Positive, Last updated: 07/10/2022 -
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Summary of opinion: Melovem
meloxicam, opinion date: 20/04/2023, Positive, Last updated: 21/04/2023 -
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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: Degarelix Accord
degarelix acetate, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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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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Summary of opinion: Ronapreve
casirivimab, imdevimab, 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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Summary of opinion: Imjudo
tremelimumab, opinion date: 22/06/2023, Positive, Last updated: 23/06/2023 -
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Summary of opinion: Evrysdi
risdiplam, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
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Summary of opinion: Kaftrio (new)
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Enhertu (new)
trastuzumab deruxtecan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Kalydeco (new)
ivacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Takhzyro (new)
lanadelumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Ryeqo (new)
relugolix, estradiol, norethisterone acetate, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Voxzogo (new)
vosoritide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Referral: Adakveo (updated)
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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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: Janus kinase inhibitors (JAKi)
tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 23/01/2023, EC decision date: 10/03/2023, Last updated: 22/05/2023 -
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Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient
associated names: Vectra 3D, Melovem, Article 82
Status: European Commission final decision, opinion/position date: 08/12/2022, EC decision date: 28/03/2023, Last updated: 14/04/2023 -
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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: 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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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
valsartan, candesartan, irbesartan, losartan, olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021 -
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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: 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