For help on how to get the results you want, see our search tips.
156 results
Medicine
Summaries of opinion Remove Summaries of opinion filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Orphan designations Remove Orphan designations filter
-
List item
Summary of opinion: Trelegy Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
List item
Summary of opinion: Elebrato Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
List item
Summary of opinion: Temybric Ellipta
fluticasone furoate, umeclidinium, vilanterol, opinion date: 25/02/2021, Negative, Last updated: 26/02/2021 -
List item
Summary of opinion: Senshio
ospemifene, opinion date: 27/01/2022, Positive, Last updated: 28/01/2022 -
List item
Summary of opinion: Amversio
betaine anhydrous, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Sitagliptin Accord
sitagliptin, opinion date: 24/02/2022, Positive, Last updated: 25/02/2022 -
List item
Summary of opinion: Yescarta
axicabtagene ciloleucel, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
List item
Summary of opinion: Retsevmo
selpercatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
List item
Summary of opinion: Ertapenem SUN
ertapenem, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Sugammadex Fresenius Kabi
sugammadex, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Sitagliptin / Metformin hydrochloride Accord
sitagliptin, metformin hydrochloride, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Ganirelix Gedeon Richter
ganirelix, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Rinvoq
upadacitinib, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Nexpovio
selinexor, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Rinvoq (new)
upadacitinib, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
List item
Summary of opinion: Nuvaxovid (new)
COVID-19 Vaccine (recombinant, adjuvanted), opinion date: 23/06/2022, Positive, Last updated: 23/06/2022 -
List item
Summary of opinion: Crysvita (new)
burosumab, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
List item
Summary of opinion: Enhertu (new)
trastuzumab deruxtecan, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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): Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy
Active substance: onasemnogene abeparvovec, DHPC type: Type II variation, Last updated: 18/03/2021 -
List item
Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Batch-specific product recall
Active substance: alpha1-proteinase inhibitor (human), DHPC type: Quality defect, Last updated: 12/02/2021 -
List item
Direct healthcare professional communication (DHPC): Respreeza (human alpha-1-proteinase inhibitor): Sterility issue with the infusion device co-packed with Respreeza 4.000 mg and 5.000 mg
Active substance: Human alpha1-proteinase inhibitor, DHPC type: Medicine shortage, Last updated: 26/03/2021 -
List item
Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet
Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020 -
List item
Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter
Active substance: Letermovir, Last updated: 11/09/2020 -
List item
Direct healthcare professional communication (DHPC): Strimvelis® (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase [ADA] cDNA sequence): first case of lymphoid T cell leukaemia after insertional oncogenesis
Active substance: autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, DHPC type: Adverse event, Last updated: 22/03/2021