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EMA recommends suspension of hydroxyprogesterone caproate medicines
The recommendation comes after studies raised possible safety concern and found 17-OHPC is not effective in preventing premature birth.
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EMA Pharmacovigilance Risk Assessment Committee (PRAC)
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CHMP meeting highlights: January 2024
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
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EMA human medicines committee (CHMP) highlights, November 2022
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.
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JAK inhibitors increase risk of cardiovascular problems and cancer, warns PRAC
Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
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EMA human medicines committee (CHMP) highlights, September 2022
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.
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EMA’s PRAC June meeting highlights
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.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, March 2022
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, January 2022
The EMA’s pharmacovigilance committee (PRAC) began reviewing terlipressin containing medicines and recommended updates to COVID-19 vaccine safety information.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, August 2021
The EMA's drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, July 2021
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
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Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
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Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) 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.
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EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks
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.
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Highlights of the EMA’s drug safety committee April meeting
In the April meeting the Pharmacovigilance Risk Assessment Committee began two new reviews of adverse events that could be caused by COVID-19 vaccines.
