Data on this website

This website contains clinical data published under the European Medicines Agency (EMA) policy on the publication of clinical data. The clinical data have been submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralised procedure and have been assessed by the Committee for Human Medicinal Products (CHMP).

EMA is the first regulatory authority worldwide to provide such broad access to clinical data.

For more information on the clinical data on this website, see Clinical data available.

For more information on EMA and its policy on the publication of clinical data, see the EMA corporate website.

Latest news

EMA is publishing clinical data for COVID-19 medicines in line with its exceptional transparency measures for COVID-19. Clinical data publication for all other centrally authorised products remains suspended until further notice.

22/06/2022: Further clinical data for COVID-19 medicine published

The clinical data for Spikevax support its use in children aged 6 to 11. More information is available on the EMA corporate website.

17/06/2022: Further clinical data for COVID-19 medicine published

The clinical data refer to interim safety and efficacy results for Spikevax. More information is available on the EMA corporate website.

16/06/2022: Clinical data for COVID-19 medicine published

The clinical data for Nuvaxovid support its marketing authorisation. More information is available on the EMA corporate website.

15/06/2022: Further clinical data for COVID-19 medicine published

The clinical data for Spikevax support the use of a booster dose in adults who received a different COVID-19 vaccine during their initial course of vaccination. More information is available on the EMA corporate website.

10/06/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data on the immunogenicity of Spikevax against the SARS-CoV-2 Delta virus variant. More information is available on the EMA corporate website.

02/06/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data for Comirnaty supporting the use of a booster dose of this COVID-19 vaccine in adolescents aged 12 to 15. More information is available on the EMA corporate website

12/05/2022: Clinical data for COVID-19 medicine published

The clinical data for Xevudy (sotrovimab) support its initial marketing authorisation. More information on this medicine is available on the EMA corporate website

13/04/2022: Further clinical data for COVID-19 medicine published

The clinical data for Comirnaty correspond to an extension of indication to include use in children aged 5 to 11. More information on this medicine is available on the EMA corporate website

11/04/2022: Further clinical data for COVID-19 medicine published

The clinical data for Veklury (remdesivir) support the renewal of its conditional marketing authorisation. More information on this medicine is available on the EMA corporate website

22/03/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data for COVID-19 Vaccine Janssen supporting the earlier recommendation that a booster dose of this vaccine can be given at least two months after the first dose. Further information about this medicine is available on the EMA corporate website.

15/03/2022: Clinical data published for medicine used for COVID-19

EMA published clinical data for Kineret (anakinra) supporting its extension of indication to include treating COVID-19 in adults with pneumonia, requiring supplemental oxygen, and who are at risk of severe respiratory failure. Further information about this medicine is available on the EMA corporate website.

14/03/2022: Clinical data for COVID-19 medicine published

EMA published the clinical data for Ronapreve (casirivimab / imdevimab) supporting its initial marketing authorisation. Further information about this medicine is available on the EMA corporate website.

11/03/2022: Clinical data for COVID-19 medicine published

EMA published the clinical data for Regkirona (regdanvimab) supporting its initial marketing authorisation. Further information about this medicine is available on the EMA corporate website.

10/03/2022: Further clinical data for COVID-19 medicine published

EMA has published further clinical data relating to Veklury (remdesivir), an antiviral medicine used to treat COVID-19. Further information on this medicine is available on the EMA corporate website

07/03/2022: Clinical data published for medicine used for COVID-19

EMA published clinical data for RoActemra (tocilizumab) supporting its use in treating COVID-19. Further information on this medicine is available on the EMA corporate website.

07/03/2022: Clinical data for COVID-19 medicine published

EMA has published the clinical data supporting the authorisation of booster doses of Moderna's COVID-19 vaccine Spikevax in adults. Health Canada also published these data at the same time. Further information on this medicine is available on the EMA corporate website

21/02/2022: Further clinical data for COVID-19 medicine published

The clinical data for Veklury (remdesivir) correspond to the extension of indication to include adults who do not require supplemental oxygen and who are at increased risk of severe COVID-19. Further information on this medicine is available on the EMA corporate website

16/02/2022: Further clinical data for COVID-19 medicine published

The clinical data for Comirnaty correspond to an extension of indication to include use in adolescents aged 12 to 15. These data were published following the unblinding of a clinical trial. Further information on this medicine is available on the EMA corporate website

02/02/2022: Further clinical data for COVID-19 medicine published

EMA has published further clinical data relating to Veklury (remdesivir), an antiviral medicine used to treat COVID-19. Further information on this medicine is available on the EMA corporate website

02/02/2022: Further clinical data for COVID-19 medicine published

The clinical data for Comirnaty refer to the authorisation of booster doses in adults. Further information on this COVID-19 vaccine is available on the EMA corporate website.  

03/11/2021: Further clinical data for COVID-19 medicine published

The clinical data for Comirnaty correspond to an extension of indication to include use in adolescents aged 12 to 15. Further information on this medicine is available on the EMA corporate website

18/10/2021: Further clinical data for COVID-19 medicine published

EMA has published further clinical data relating to Veklury (remdesivir), an antiviral medicine used to treat COVID-19. Further information on this medicine is available on the EMA corporate website

10/09/2021: Further clinical data for COVID-19 medicine published

EMA has published updated documents for Comirnaty with fewer redactions, following the unblinding of a trial that was ongoing when EMA first released the data supporting its authorisation. Further information on this medicine is available on the EMA corporate website

18/08/2021: Clinical data for COVID-19 medicine published

EMA has published the clinical data supporting the renewal of the conditional marketing authorisation for Veklury (remdesivir), an antiviral medicine used to treat COVID-19. Further information on this medicine is available on the EMA corporate website.

30/07/2021: Clinical data for new COVID-19 medicine published

Vaxzevria is a vaccine for preventing COVID-19 in people aged 18 years and older. EMA has published the clinical data supporting the granting of a conditional marketing authorisation. Further information on this medicine is available on the EMA corporate website.

27/07/2021: Clinical data for new COVID-19 medicine published

COVID-19 Vaccine Janssen is a vaccine for preventing COVID-19 in people aged 18 years and older. EMA has published the clinical data supporting the granting of a conditional marketing authorisation. Further information on this medicine is available on the EMA corporate website.

22/07/2021: Further clinical data for COVID-19 medicine published

EMA published the participant safety narratives for Comirnaty. Further information on this medicine is available on the EMA corporate website.

Latest clinical data published

Spikevax (Elasomeran) EMEA/H/C/005791/II/0041 published 22 June 2022

SPIKEVAX (Elasomeran) EMEA/H/C/005791/SOB/010 published 17 June 2022

NUVAXOVID (SARS-CoV-2, spike protein, recombinant, expressed in Sf9 cells derived from Spodoptera frugiperda) EMEA/H/C/005808/0000 published 16 June 2022

SPIKEVAX (Elasomeran) EMEA/H/C/005791/II/0042 published 15 June 2022

SPIKEVAX (ELASOMERAN) EMEA/H/C/005791/II/0047 published 10 June 2022

COMIRNATY (TOZINAMERAN) EMEA/H/C/005735/II/0111 published 2 June 2022

Xevudy (Sotrovimab) EMEA/H/C/005676/0000 published 12 May 2022

COMIRNATY (Tozinameran) EMEA/H/C/005735/X/0077 published 13 April 2022

SPIKEVAX (COVID-19 mRNA Vaccine (nucleoside-modified)) EMEA/H/C/005791/II/0034 published 12 April 2022

VEKLURY (Remdesivir) EMEA/H/C/005622/R/0031 published 11 April 2022

 

 

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