For help on how to get the results you want, see our search tips.
77 results
-
List item
Summary of opinion: Albrioza
sodium phenylbutyrate, Ursodoxicoltaurine, opinion date: 22/06/2023, Negative, Last updated: 06/07/2023 -
List item
Summary of opinion: Inaqovi
cedazuridine, decitabine, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Bylvay
odevixibat, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Tepkinly
epcoritamab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Tevimbra
tislelizumab, opinion date: 20/07/2023, Positive, Last updated: 21/07/2023 -
List item
Summary of opinion: Revestive
teduglutide, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Refixia
nonacog beta pegol, opinion date: 22/06/2023, Positive, Last updated: 23/06/2023 -
List item
Summary of opinion: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Jaypirca
pirtobrutinib, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Camzyos
mavacamten, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Adcetris (new)
brentuximab vedotin, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Kaftrio (new)
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Yorvipath (new)
Palopegteriparatide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Takhzyro (new)
lanadelumab, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Finlee (new)
dabrafenib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Vanflyta (new)
quizartinib, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Ryeqo (new)
relugolix, estradiol, norethisterone acetate, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Voxzogo (new)
vosoritide, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: ZILBRYSQ (new)
Zilucoplan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Enhertu (new)
trastuzumab deruxtecan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
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 -
List item
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 -
List item
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 -
List item
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 -
List item
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