European Medicines Agency |

05/03/2021

EMA website briefly unavailable on 8 March 2021

The European Medicines Agency's (EMA) corporate website ( www.ema.europa.eu ) will be intermittently unavailable between 21:00 and 22:00 (Central European Time, CET) on 8 March 2021 due to essential maintenance. During this time, a holding page will...

04/03/2021 COVID-19

EMA starts rolling review of the Sputnik V COVID-19 vaccine

EMA’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine 1 developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The EU applicant for this medicine is R-Pharm...

02/03/2021 COVID-19

EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine

Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada collaboratively published the full clinical data reviewed as part of their authorisations of the Moderna COVID-19 vaccine . This...

26/02/2021

First oral treatment for spinal muscular atrophy (SMA) recommended for approval

EMA has recommended granting a marketing authorisation in the European Union for the first treatment that can be given orally to patients with certain types of spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle...

26/02/2021 COVID-19

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2021

Six new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended six medicines for approval at its February 2021 meeting. The Committee recommended granting a marketing authorisation for Evrysdi* (risdiplam), the first...

25/02/2021 COVID-19

Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers

EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address coronavirus (SARS-CoV-2) variants . Currently, three vaccines are authorised for use in the EU: Comirnaty , COVID-19...

COVID-19 pandemic

QUICK LINKS

Monthly safety updates for Comirnaty and Moderna

Monthly safety updates for Comirnaty and Moderna

Start of rolling review: Sputnik V COVID-19 vaccine

Start of rolling review: Sputnik V COVID-19 vaccine

Global cooperation on COVID-19 medicine regulation

Global cooperation on COVID-19 medicine regulation

EMA issues guidance to address coronavirus variants

EMA issues guidance to address coronavirus variants

Latest news

EMA website briefly unavailable on 8 March 2021

EMA starts rolling review of the Sputnik V COVID-19 vaccine

EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine

First oral treatment for spinal muscular atrophy (SMA) recommended for approval

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 February 2021

Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers

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