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73 results
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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: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
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Summary of opinion: Kaftrio
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Ryeqo
relugolix, estradiol, norethisterone acetate, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
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Summary of opinion: Jemperli
dostarlimab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Rubraca
rucaparib, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Veyvondi
vonicog alfa, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Brukinsa
zanubrutinib, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Summary of opinion: Fluad Tetra (new)
influenza vaccine (surface antigen, inactivated, adjuvanted), opinion date: 10/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Evkeeza (new)
evinacumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Talzenna (new)
talazoparib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: NexoBrid (new)
concentrate of proteolytic enzymes enriched in bromelain, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Ayvakyt (new)
avapritinib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
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Summary of opinion: Imfinzi
durvalumab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
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Direct healthcare professional communication (DHPC): Ozempic (semaglutide) and Victoza (liraglutide): Supply shortage (updated)
Active substance: semaglutide, liraglutide, DHPC type: Medicine shortage, Last updated: 21/11/2023 -
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Referral: Ocaliva (updated)
obeticholic acid, associated names: Ocaliva, Article 20 procedures
Status: Procedure started, Last updated: 10/11/2023 -
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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
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