For help on how to get the results you want, see our search tips.
42 results
Medicine type
Additional monitoring Remove Additional monitoring filter
Exceptional circumstances Remove Exceptional circumstances filter
Accelerated assessment Remove Accelerated assessment 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: 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: 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: Zokinvy
lonafarnib, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
List item
Summary of opinion: Upstaza
eladocagene exuparvovec, 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 -
List item
Direct healthcare professional communication (DHPC): Venclyxto - (venetoclax) film coated tablets: Updated recommendations on tumour lysis syndrome (TLS) in CLL patients
Active substance: Venetoclax, DHPC type: Type II variation, Last updated: 10/06/2021 -
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): Supply Constraint of Sarilumab [Kevzara®]
Active substance: sarilumab, DHPC type: Medicine shortage, Last updated: 09/11/2021 -
List item
Direct healthcare professional communication (DHPC): Beovu ® (brolucizumab): Updated recommendations to minimise the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion
Active substance: Brolucizumab, DHPC type: Type II variation, Last updated: 05/11/2021