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Withdrawn application: Gavreto
pralsetinib, date of withdrawal: 03/11/2022, Post-authorisation, Last updated: 02/02/2023 -
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Withdrawn application: Imcivree
setmelanotide, date of withdrawal: 22/04/2022, Post-authorisation, Last updated: 28/09/2022 -
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Withdrawn application: Zydelig
idelalisib, date of withdrawal: 30/01/2018, Post-authorisation, Last updated: 23/02/2018 -
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Withdrawn application: Translarna
ataluren, date of withdrawal: 06/03/2017, Post-authorisation, Last updated: 24/03/2017 -
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Withdrawn application: Rienso
ferumoxytol, date of withdrawal: 19/01/2015, Post-authorisation, Last updated: 27/02/2015 -
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Withdrawn application: Omontys
date of withdrawal: 28/06/2013, Initial authorisation, Last updated: 28/06/2013 -
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Withdrawn application: Memantine FGK
memantine, date of withdrawal: 18/12/2012, Initial authorisation, Last updated: 10/04/2013 -
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Withdrawn application: Revlimid
lenalidomide, date of withdrawal: 20/06/2012, Post-authorisation, Last updated: 06/07/2012 -
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Withdrawn application: Evoltra
clofarabine, date of withdrawal: 18/03/2008, Post-authorisation, Last updated: 19/03/2008 -
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Withdrawn application: Glivec
imatinib, date of withdrawal: 18/10/2006, Post-authorisation, Last updated: 23/10/2006 -
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Withdrawn application: Tookad
padeliporfin, date of withdrawal: 14/12/2021, Post-authorisation, Last updated: 28/01/2022 -
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Withdrawn application: Iclusig (new)
ponatinib, date of withdrawal: 11/08/2023, Post-authorisation, Last updated: 14/09/2023 -
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Withdrawn application: Gazyvaro
obinutuzumab, date of withdrawal: 04/07/2023, Post-authorisation, Last updated: 21/07/2023 -
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Direct healthcare professional communication (DHPC): Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)) suspension for injection in pre-filled syringe: Important information regarding the potential for breakage of Vaxneuvance pre-filled syringes (updated)
Active substance: Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed), DHPC type: Quality defect, Last updated: 20/09/2023 -
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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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Direct healthcare professional communication (DHPC): Potential missing package leaflet in folding boxes of RoActemra (tocilizumab), Hemlibra (emicizumab), Herceptin (trastuzumab), Kadcyla (trastuzumab emtansine), MabThera (rituximab), Phesgo (pertuzumab / trastuzumab) and Tecentriq (atezolizumab)
Active substance: tocilizumab, Emicizumab, trastuzumab, trastuzumab emtansine, rituximab, pertuzumab, trastuzumab, atezolizumab, DHPC type: Quality defect, Last updated: 17/08/2023 -
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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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Direct healthcare professional communication (DHPC): Ozempic (semaglutide) solution for injection in pre-filled pen: supply shortage update
Active substance: semaglutide, DHPC type: Medicine shortage, Last updated: 13/03/2023 -
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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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Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone): Discontinuation of manufacturing at the end of 2024 and update on 100mcg shortage
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 04/10/2022 -
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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: 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