Add this result to my export selection European Pharmacovigilance Risk Assessment Committee (PRAC) concludes that use of remdesivir is not associated with kidney problems Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 12 February 2021 The European Medicines Agency’s PRAC has assessed all available information and concluded there is currently no evidence indicating that reported kidney problems are associated with the use of... Read Summary Type: Medicines Current Awareness (Remove filter) Type: Safety Alerts (Add filter)
Add this result to my export selection European PRAC concludes safety signal of anaphylaxis with COVID-19 Vaccine AstraZeneca Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 12 March 2021 Following a review of the available data, the European PRAC has recommended an update to the product information to include anaphylaxis and hypersensitivity as side effects and to update the existing... Read Summary Type: Medicines Current Awareness (Remove filter) Type: Safety Alerts (Add filter)
Add this result to my export selection European PRAC concludes benefits of ifosfamide solutions continue to outweigh risks Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 12 March 2021 Two recent studies suggested the known risk of encephalopathy is higher with the solution than with the powder form. The PRAC concluded this could not be excluded and has recommended the existing... Read Summary Type: Medicines Current Awareness (Remove filter) Type: Safety Alerts (Add filter)
Add this result to my export selection COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 18 March 2021 The European PRAC has concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca and confirmed its benefits in combating the still widespread... Read Summary SPS comment Type: Medicines Current Awareness (Remove filter) Type: Safety Alerts (Add filter)
Add this result to my export selection COVID-19 vaccine safety update – Comirnaty (Pfizer/BioNTech COVID-19 vaccine) (PDF) Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 28 January 2021 The EMA has released its first safety update on a COVID-19 vaccine. Data collected since its authorisation is consistent with the known safety profile of the vaccine; no new side effects were... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP clarifies Pfizer/BioNTech COVID-19 vaccine (Comirnaty) dosage interval Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 28 January 2021 The EU product information for Comirnaty has been updated to clarify the European CHMP’s position on the interval between doses. It now recommends the second dose be administered 3 weeks after the... Read Summary SPS comment Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 16 February 2021 The CHMP will assess the vaccine under an accelerated timetable aiming to issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection International cooperation to align approaches for regulation of COVID-19 vaccines and medicines Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 25 February 2021 This was highlighted in series of regulatory workshops focusing on 3 areas: responding to emerging COVID-19 virus variants, addressing knowledge gaps regarding vaccines and treatments in... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European Medicines Agency starts rolling review of Celltrion antibody regdanvimab for COVID-19 Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 24 February 2021 The decision to start the rolling review is based on preliminary results from an ongoing study looking at the ability of regdanvimab to treat COVID-19. The rolling review will continue until enough... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection Human medicines: highlights of 2020 Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 21 January 2021 The EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human use. 97 medicines were recommended for marketing authorisation. Read Summary Type: Medicines Current Awareness (Remove filter)