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35 results
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Summary of opinion: Steglatro
ertugliflozin, opinion date: 16/09/2021, Positive, Last updated: 30/09/2021 -
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Summary of opinion: Rivaroxaban Mylan
rivaroxaban, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Sitagliptin SUN
sitagliptin fumarate, opinion date: 14/10/2021, Positive, Last updated: 15/10/2021 -
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Summary of opinion: Lenvima
lenvatinib, opinion date: 14/10/2021, Positive, Last updated: 15/10/2021 -
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Summary of opinion: Ultomiris
ravulizumab, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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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: Dengvaxia (new)
dengue tetravalent vaccine (live, attenuated), opinion date: 11/11/2021, Positive, Last updated: 12/11/2021 -
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Summary of opinion: Epclusa (new)
sofosbuvir, velpatasvir, opinion date: 11/11/2021, Positive, Last updated: 12/11/2021 -
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Summary of opinion: Kaftrio (new)
ivacaftor, tezacaftor, elexacaftor, opinion date: 11/11/2021, Positive, Last updated: 12/11/2021 -
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Summary of opinion: Segluromet
ertugliflozin, metformin hydrochloride, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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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: Trelegy Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
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Summary of opinion: Zepatier
elbasvir, grazoprevir, opinion date: 16/09/2021, Positive, Last updated: 17/09/2021 -
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Summary of opinion: Zeposia
ozanimod, opinion date: 14/10/2021, Positive, Last updated: 15/10/2021 -
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Summary of opinion: Xeljanz
tofacitinib, opinion date: 14/10/2021, Positive, Last updated: 15/10/2021 -
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Summary of opinion: Skyrizi
risankizumab, opinion date: 14/10/2021, Positive, Last updated: 15/10/2021 -
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Referral: Nomegestrol and chlormadinone (updated)
nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: Procedure started, Last updated: 04/11/2021 -
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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: 11/10/2021 -
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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 -
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Referral: Xeljanz
tofacitinib, associated names: Xeljanz, Article 20 procedures
Status: European Commission final decision, opinion/position date: 14/11/2019, EC decision date: 31/01/2020, Last updated: 06/03/2020 -
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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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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: 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: 19/03/2019