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The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) finds the benefits of amfepramone medicines do not outweigh their risks and addressed possible links between COVID-19 vaccines and menstruation.
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
The EMA’s pharmacovigilance committee (PRAC) began reviewing terlipressin containing medicines and recommended updates to COVID-19 vaccine safety information.
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
The EMA's drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
In the April meeting the Pharmacovigilance Risk Assessment Committee began two new reviews of adverse events that could be caused by COVID-19 vaccines.
The EMA’s drug safety committee concluded that the vaccine is not associated with an increased risk of thromboembolic events and that its benefits still outweigh its risks.
Several countries have temporarily stopped the use of the vaccine while reports of blood clots are investigated by the EMA’s pharmacovigilance committee and other authorities.
