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23/07/2021 COVID-19

COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine Moderna) to include use in children aged 12 to 17 years. The vaccine is already authorised for...

23/07/2021

CHMP endorses review finding no link between viral vector in Zynteglo and blood cancer

EMA’s human medicines committee (CHMP) has endorsed findings of a review which concluded that there is no evidence Zynteglo causes a blood cancer known as acute myeloid leukaemia (AML). Zynteglo, a gene therapy for the blood disorder beta...

23/07/2021

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021

Two new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended two medicines for approval at its July 2021 meeting. The Committee adopted a positive opinion for Nexviadyme * (avalglucosidase alfa), intended for the...

22/07/2021 COVID-19

COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect

Guillain-Barré syndrome (GBS) will be listed as a very rare side effect of COVID-19 Vaccine Janssen and a warning will be included in the product information to raise awareness among healthcare professionals and people taking the vaccine. GBS is a...

21/07/2021

The European Medicines Agency mourns the passing of Jordi Llinares Garcia

It is with great sadness that EMA announces the death of Jordi Llinares Garcia, the Agency’s Head of Research and Innovation, who passed away unexpectedly in his sleep. He was 52 and leaves behind his wife and four children. Jordi will be dearly...

20/07/2021 COVID-19

EMA starts rolling review of COVID-19 vaccine Vidprevtyn

EMA’s human medicines committee (CHMP) has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical...

COVID-19 pandemic

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CHMP highlights: July 2021

CHMP highlights: July 2021

Spikevax approved for adolescents in the EU

Spikevax approved for adolescents in the EU

Update on safety of COVID-19 Vaccine Janssen

Update on safety of COVID-19 Vaccine Janssen

ePI public consultation

ePI public consultation

Latest news

COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU

CHMP endorses review finding no link between viral vector in Zynteglo and blood cancer

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021

COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect

The European Medicines Agency mourns the passing of Jordi Llinares Garcia

EMA starts rolling review of COVID-19 vaccine Vidprevtyn

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