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 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 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 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 European CHMP recommends license extension of cabozantinib (Cabometyx) as first-line treatment for advanced renal cell carcinoma Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 26 February 2021 The proposed license extension is as monotherapy for the treatment of advanced renal cell carcinoma (RCC) and in combination with nivolumab for the first-line treatment of advanced RCC in adults. Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends license extension of cannabidiol (Epidyolex) Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 26 February 2021 The proposed license extension is for use as adjunctive therapy of seizures associated with tuberous sclerosis complex for patients 2 years of age and older. Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends license extension of delafloxacin (Quofenix) Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 26 February 2021 The proposed license extension is for the treatment of community- acquired pneumonia in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of isatuximab (Sarclisa) Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 26 February 2021 The proposed license extension is in combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of two bevacizumab biosmilars (Abevmy and Lextemy) Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 26 February 2021 Studies found that both these brands were highly similar with comparable quality, safety and efficacy to the reference product Avastin. They will be licensed for the range of indications as per... Read Summary Type: Medicines Current Awareness (Remove filter)
Add this result to my export selection European CHMP recommends approval of berotralstat (Orladeyo) for prevention of recurrent attacks of hereditary angioedema (HAE) Source: European Medicines Agency - EMA (Remove filter) Published by European Medicines Agency, 26 February 2021 Berotralstat is an oral inhibitor of plasma kallikrein which acts by reducing the release of bradykinin, a potent vasodilator involved in HAE attacks. In clinical trials, HAE attacks were reduced by... Read Summary Type: Medicines Current Awareness (Remove filter)