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55 results
Medicine
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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: Elebrato 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: Maviret
glecaprevir, pibrentasvir, opinion date: 22/04/2021, Positive, Last updated: 26/04/2021 -
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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: Galafold (new)
migalastat, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Rinvoq (new)
upadacitinib, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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Summary of opinion: Xeljanz (new)
tofacitinib, opinion date: 24/06/2021, Positive, Last updated: 25/06/2021 -
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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: Keytruda
pembrolizumab, opinion date: 20/05/2021, Positive, Last updated: 21/05/2021 -
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Summary of opinion: Vosevi (new)
sofosbuvir, velpatasvir, voxilaprevi, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Deltyba (new)
delamanid, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Ultomiris (new)
ravulizumab, opinion date: 22/07/2021, Positive, Last updated: 23/07/2021 -
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Summary of opinion: Spikevax (previously COVID-19 Vaccine Moderna) (new)
COVID-19 mRNA Vaccine (nucleoside modified), opinion date: 23/07/2021, Positive, Last updated: 23/07/2021 -
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Referral: Zynteglo (updated)
betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 22/07/2021, Last updated: 23/07/2021 -
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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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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: 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 -
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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: 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