For help on how to get the results you want, see our search tips.
32 results
Medicine
Summaries of opinion Remove Summaries of opinion filter
Direct healthcare professional communication Remove Direct healthcare professional communication filter
Medicine type
Conditional approval Remove Conditional approval filter
Exceptional circumstances Remove Exceptional circumstances filter
Biosimilar Remove Biosimilar filter
Categories
Human Remove Human filter
-
List item
Summary of opinion: Tuznue (updated)
trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 24/06/2022 -
List item
Summary of opinion: Hervelous (updated)
trastuzumab, opinion date: 19/05/2022, Negative, Last updated: 24/06/2022 -
List item
Summary of opinion: Retsevmo
selpercatinib, opinion date: 22/04/2022, Positive, Last updated: 22/04/2022 -
List item
Summary of opinion: Kinpeygo
budesonide, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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: Nexpovio
selinexor, opinion date: 19/05/2022, Positive, Last updated: 20/05/2022 -
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
Summary of opinion: Ranivisio (new)
ranibizumab, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
List item
Summary of opinion: Vegzelma (new)
bevacizumab, opinion date: 23/06/2022, Positive, Last updated: 21/06/2022 -
List item
Summary of opinion: Roctavian (new)
Valoctocogene roxaparvovec, opinion date: 23/06/2022, Positive, Last updated: 24/06/2022 -
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): 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): 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): Polivy (polatuzumab vedotin) 140 mg powder for concentrate for solution for injection: Important information on plastic vial flip-off cap colour
Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020 -
List item
Direct healthcare professional communication (DHPC): Infliximab (Remicade, Flixabi, Inflectra, Remsima and Zessly): Use of live vaccines in infants exposed in utero or during breastfeeding
Active substance: infliximab, DHPC type: New contraindication, Last updated: 07/03/2022 -
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) (new)
Active substance: defibrotide, DHPC type: Lack of effect, Safety signal, Last updated: 13/06/2022 -
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 (new)
Active substance: Obeticholic acid, DHPC type: New contraindication, Last updated: 09/06/2022 -
List item
Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone) 100 micrograms/dose powder and solvent for solution for injection: expected shortage from June 30th, 2022
Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 29/04/2022 -
List item
Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Risk of thrombocytopenia and coagulation disorders
Active substance: Chimpanzee Adenovirus encoding the SARS CoV 2 Spike glycoprotein (ChAdOx1-S), DHPC type: Safety signal, Last updated: 24/03/2021 -
List item
Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 13/04/2021 -
List item
Direct healthcare professional communication (DHPC): Vaxzevria/COVID-19 Vaccine AstraZeneca: Risk of thrombosis in combination with thrombocytopenia - Updated information
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Type II variation, Last updated: 02/06/2021 -
List item
Direct healthcare professional communication (DHPC): Vaxzevria (previously COVID-19 Vaccine AstraZeneca): contraindication in individuals with previous capillary leak syndrome
Active substance: ChAdOx1-SARS-COV-2, DHPC type: Safety signal, Last updated: 23/06/2021