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Highlights of the Safety committee: November 2022
MEDICINES |COMMITTEESHighlights of the Safety committee: November 2022
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Highlights of the Safety committee: November 2022
MEDICINES |COMMITTEESHighlights of the Safety committee: November 2022
PRAC finalised the review of heavy menstrual bleeding with COVID-19 mRNA vaccines, confirmed the withdrawal of amfepramone obesity medicines, and recommended measures for JAK inhibitors
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Use of mRNA COVID-19 vaccines in young children
COVID-19 |VaccinesUse of mRNA COVID-19 vaccines in young children
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Use of mRNA COVID-19 vaccines in young children
COVID-19 |VaccinesUse of mRNA COVID-19 vaccines in young children
EMA recommended authorising the use of Comirnaty in children aged 6 months to 4 years, and Spikevax for those aged 6 months to 5 years
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New adapted COVID-19 vaccine
COVID-19 |VaccinesNew adapted COVID-19 vaccine
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New adapted COVID-19 vaccine
COVID-19 |VaccinesNew adapted COVID-19 vaccine
This adapted version of Spikevax targets the Omicron subvariants BA.4 and BA.5. It is meant for use in vaccinated people aged 12 and over
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EMA's response to monkeypox
Monkeypox |VaccinesEMA's response to monkeypox
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EMA's response to monkeypox
Monkeypox |VaccinesEMA's response to monkeypox
Find out about monkeypox disease, medicines available in the EU to tackle it and how EMA and its EU partners are helping to combat the outbreak
Latest news
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List item28/10/2022
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 24 - 27 October 2022
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated with...
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List item28/10/2022
EMA confirms recommendation to withdraw marketing authorisations for amfepramone medicines
EMA’s safety committee (PRAC) has confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This follows a re-examination of its previous recommendation of June 2022, which was requested by the...
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List item28/10/2022
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
EMA’s safety committee (PRAC) has recommended measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular...
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List item28/10/2022 COVID-19
EMA business hours over All Saints' Day and All Souls' Day, 1 and 2 November
The European Medicines Agency's (EMA) office is closed on Tuesday 1 November and Wednesday 2 November 2022. Essential work related to the COVID -19 pandemic will continue on these days. Outside of working hours and on public holidays, it is possible...
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List item19/10/2022 COVID-19
EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
EMA’s human medicines committee (CHMP) has recommended extending the use of Comirnaty and Spikevax targeting the original strain of SARS-CoV-2. The Committee recommended including the use in children aged 6 months to 4 years for Comirnaty and use in...
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List item19/10/2022 COVID-19
EMA recommends approval of second adapted Spikevax vaccine
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Spikevax COVID-19 vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. The adapted vaccine, Spikevax bivalent Original...
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