First COVID-19 vaccine safety update published

29 January 2021 - Today EMA has released its first safety update on a COVID-19 vaccine — Comirnaty.  ...

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Global regulators highlight key role of health care professionals in fostering confidence in COVID-19 vaccines

19 January 2021 - EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities ...

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Norway finds no direct link between elderly deaths and vaccine

19 January 2021 - Health authorities in Norway say there's no evidence of a direct link between the recent string ...

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EU regulator starts safety review of coronavirus drug

3 October 2020 - The European Medicines Agency says it has started a safety review after some patients taking the ...

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How incidents with medicines are managed in the EU – a ten year analysis

23 September 2020 - The EU medicines network is supported by a robust regulatory framework with defined processes and clear ...

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European Medicines Agency approves safety label update for Novartis Beovu

14 September 2020 - Novartis worked with the EMA to update the Beovu (brolucizumab) label to guide physicians in their treatment ...

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PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids

4 September 2020 - A review by EMA’s safety committee has confirmed that 5 mg ulipristal acetate (Esmya and generic ...

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International regulators stress value of safe and effective vaccines

18 June 2020 - EMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the ...

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COVID-19: reminder of the risks of chloroquine and hydroxychloroquine

29 May 2020 - The EMA is reminding health care professionals to closely monitor patients with COVID-19 who are receiving ...

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Reporting suspected side effects of medicines in patients with COVID-19

24 April 2020 - EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) ...

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COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine

23 April 2020 - Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated ...

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EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic

27 March 2020 - EMA is aware of recent media reports and publications which question whether some medicines, for instance ...

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Six-year review shows success of the EU signal management system in improving safe use of medicines

11 December 2019 - In the first six years since the implementation of the 2012 EU pharmacovigilance legislation, the EU ...

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Working together for safe medicines in the EU

6 May 2019 - EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines ...

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Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing

12 April 2019 - EMA has started a review of the multiple sclerosis medicine Lemtrada (alemtuzumab) following new reports of ...

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