Adcetris, Zelboraf & Stelara on new EMA list of safety actions
This article was originally published in SRA
The European Medicines Agency has published the first monthly overview of recommendations by its pharmacovigilance risk assessment committee (PRAC) regarding actual or potential safety issues with products marketed in the EU. Among the products requiring a safety update is Takeda's Adcetris (brentuximab vedotin), while additional information has been requested for a number of drugs including Roche's Zelboraf (vemurafenib), Janssen's Stelara (ustekinumab) and Amgen's Prolia/Xgeva (denosumab).
You may also be interested in...
The UK government says it is on track to vaccinate the 15 million most vulnerable people by mid-February, and that a “major study” is under way to assess the potential impact of the new UK variant on vaccine efficacy.
Coronavirus Notebook: EU To Buy 30 Million Doses Of Valneva Vaccine, Russia To Issue Compulsory License For Remdesivir
The European Medicines Agency says hacked COVID-19 vaccine data has been leaked online, and Australia’s chief medical officer defends the Oxford/AstraZeneca vaccine against scientists’ claim that it is not effective enough.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.