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.

16/09/2022: Further clinical data published for medicine used for COVID-19

The clinical data for Kineret (anakinra) includes final study results on efficacy and safety data. Further information about this medicine is available on the EMA corporate website.

29/08/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data supporting the use of a booster dose of COVID-19 vaccine Spikevax in adolescents aged 12 to 18. More information is available on the EMA corporate website.

26/08/2022: Further clinical data for COVID-19 medicine published 

EMA published clinical data supporting the marketing authorisation of COVID-19 treatment Veklury. More information is available on the EMA corporate website.

01/08/2022: Further clinical data for COVID-19 medicine published

EMA published six-month follow-up data on the efficacy, safety and tolerability of two doses of Comirnaty in adolescents aged 12 to 15. More information is available on the EMA corporate website.

21/07/2022: Further clinical data for COVID-19 medicine published

EMA published the clinical data supporting a booster dose of Comirnaty in adults who received a different COVID-19 vaccine during their initial course of vaccination. More information is available on the EMA corporate website.

11/07/2022: Further clinical data for COVID-19 medicine published

The clinical data for Veklury support its December 2021 extension of indication to include treating adults who do not require supplemental oxygen and who are at increased risk of severe COVID-19. More information is available on the EMA corporate website.

06/07/2022: Further clinical data for COVID-19 medicine published

The clinical data for Comirnaty include efficacy and safety updates on the use of its booster dose in participants aged 16 and older. More information is available on the EMA corporate website.

06/07/2022: Clinical data for COVID-19 medicine published

EMA published clinical data supporting the marketing authorisation of COVID-19 treatment Paxlovid (PF-07321332 / ritonavir). More information is available on the EMA corporate website.

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.  

Latest clinical data published

Kineret (Anakinra) EMEA/H/C/000363/II/0087 published 16 September 2022

SPIKEVAX (Elasomeran) EMEA/H/C/005791/II/0057 published 29 August 2022

Veklury (Remdesivir) EMEA/H/C/005622/II/0034/G published 26 August 2022

COMIRNATY (Tozinameran) EMEA/H/C/005735/II/0102 published 1 August 2022

COMIRNATY (Tozinameran) EMEA/H/C/005735/II/0104 published 21 July 2022

Veklury (Remdesivir) EMEA/H/C/005622/II/0036 published 11 July 2022

Paxlovid ((1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide / Ritonavir) EMEA/H/C/005973/0000 published 6 July 2022

COMIRNATY (Tozinameran) EMEA/H/C/005735/II/0093 published 6 July 2022

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

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

 

 

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