For help on how to get the results you want, see our search tips.
34 results
Medicine type
Generic Remove Generic filter
Exceptional circumstances Remove Exceptional circumstances filter
Accelerated assessment Remove Accelerated assessment filter
Orphan medicine Remove Orphan medicine filter
Conditional approval Remove Conditional approval filter
Medicine
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Summaries of opinion Remove Summaries of opinion filter
Categories
Human Remove Human filter
-
List item
Summary of opinion: Plerixafor Accord
plerixafor, opinion date: 13/10/2022, Positive, Last updated: 18/10/2022 -
List item
Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 10/11/2022, Positive, Last updated: 11/11/2022 -
List item
Summary of opinion: Imcivree
setmelanotide, opinion date: 21/07/2022, Positive, Last updated: 22/07/2022 -
List item
Summary of opinion: Libtayo
cemiplimab, opinion date: 13/10/2022, Positive, Last updated: 14/10/2022 -
List item
Summary of opinion: Dimethyl fumarate Accord
dimethyl fumarate, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
List item
Summary of opinion: Enhertu
trastuzumab deruxtecan, opinion date: 15/12/2022, Positive, Last updated: 14/12/2022 -
List item
Summary of opinion: Hemlibra
emicizumab, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
List item
Summary of opinion: Fintepla
fenfluramine, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
List item
Summary of opinion: Hemgenix
etranacogene dezaparvovec, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
List item
Summary of opinion: Imjudo
tremelimumab, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
List item
Summary of opinion: Pombiliti
cipaglucosidase alfa, opinion date: 15/12/2022, Positive, Last updated: 16/12/2022 -
List item
Summary of opinion: Omblastys
iodine (131I) omburtamab, opinion date: 15/12/2022, Negative, Last updated: 16/12/2022 -
List item
Summary of opinion: Trecondi (new)
treosulfan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
List item
Summary of opinion: Wakix (new)
pitolisant, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
List item
Summary of opinion: Dapagliflozin Viatris (new)
dapagliflozin, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
List item
Summary of opinion: Reblozyl (new)
luspatercept, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
List item
Summary of opinion: Tolvaptan Accord (new)
tolvaptan, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
List item
Summary of opinion: Sitagliptin / Metformin hydrochloride Sun (new)
sitagliptin, metformin hydrochloride, opinion date: 26/01/2023, Positive, Last updated: 27/01/2023 -
List item
Summary of opinion: Sohonos (new)
palovarotene, opinion date: 26/01/2023, Negative, Last updated: 27/01/2023 -
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): Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy
Active substance: Lomitapide, DHPC type: Post-authorisation measure, Last updated: 17/02/2021 -
List item
Direct healthcare professional communication (DHPC): Defitelio (defibrotide): Do not use for prophylaxis of veno-occlusive disease (VOD) after post-hematopoietic stem-cell transplantation (HSCT)
Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022 -
List item
Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa
Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020 -
List item
Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization
Active substance: andexanet alfa, DHPC type: Adverse event, Last updated: 04/11/2020 -
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