For help on how to get the results you want, see our search tips.
59 results
Medicine
Shortages Remove Shortages filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Summaries of opinion Remove Summaries of opinion filter
Medicine type
Exceptional circumstances Remove Exceptional circumstances filter
Conditional approval Remove Conditional approval filter
Additional monitoring Remove Additional monitoring filter
Categories
Human Remove Human filter
-
List item
Summary of opinion: Bylvay
odevixibat, 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: Ronapreve
casirivimab, imdevimab, opinion date: 26/04/2023, Positive, Last updated: 26/04/2023 -
List item
Summary of opinion: Kaftrio
ivacaftor, tezacaftor, elexacaftor, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Ryeqo
relugolix, estradiol, norethisterone acetate, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 14/09/2023, Positive, Last updated: 15/09/2023 -
List item
Summary of opinion: Loargys
Pegzilarginase, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Jemperli
dostarlimab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Rubraca
rucaparib, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Veyvondi
vonicog alfa, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Brukinsa
zanubrutinib, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Elrexfio
elranatamab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
Summary of opinion: Fluad Tetra (new)
influenza vaccine (surface antigen, inactivated, adjuvanted), opinion date: 10/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Evkeeza (new)
evinacumab, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Talzenna (new)
talazoparib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: NexoBrid (new)
concentrate of proteolytic enzymes enriched in bromelain, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Krazati (new)
adagrasib, opinion date: 09/11/2023, Positive, Last updated: 10/11/2023 -
List item
Summary of opinion: Imfinzi
durvalumab, opinion date: 12/10/2023, Positive, Last updated: 13/10/2023 -
List item
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 -
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
Active substance: Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed), DHPC type: Quality defect, Last updated: 20/09/2023 -
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
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 -
List item
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 -
List item
Direct healthcare professional communication (DHPC): Picato (ingenol mebutate): Suspension of the marketing authorisation due to risk of skin malignancy
Active substance: Ingenol mebutate, DHPC type: Interim measures, Referral - Article 20 procedure, Last updated: 14/02/2020 -
List item
Direct healthcare professional communication (DHPC): Ocaliva (obeticholic acid): New contraindication for the treatment of primary biliary cholangitis (PBC) in patients with decompensated liver cirrhosis or a history of prior hepatic decompensation
Active substance: Obeticholic acid, DHPC type: New contraindication, Last updated: 09/06/2022