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.

26/01/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Veklury support a study report on the efficacy and safety of this COVID-19 treatment. More information is available on the EMA corporate website

26/01/2023: Clinical data for COVID-19 medicine published.

The clinical data for COVID-19 Vaccine Valneva support its use in adults aged 18 to 50. More information is available on the EMA corporate website

23/01/2023: Further clinical data for COVID-19 medicine published.

The clinical data for Comirnaty support a new strength for its Original/Omicron BA.4-5 version for vaccination in children aged 5 to 11 who have previously received at least a primary vaccination course against COVID-19. More information is available on the EMA corporate website.

21/12/2022: Further clinical data for COVID-19 medicine published

The clinical data for Spikevax support the authorisation of its adapted BA.1 version. More information is available on the EMA corporate website.

21/12/2022: Further clinical data for COVID-19 medicine published

The clinical data for Jcovden support updating the list of side effects in its summary of product characteristics. More information is available on the EMA corporate website.

29/11/2022: Further clinical data for COVID-19 medicine published

The clinical data for Veklury support updating prescribing information in the summary of product characteristics for this COVID-19 treatment. More information is available on the EMA corporate website.

29/11/2022: Further clinical data for COVID-19 medicine published

The clinical data for Vaxzevria support the final study report on the link between vaccination with this COVID-19 vaccine and thrombocytopenia syndrome (TTS). More information is available on the EMA corporate website.

14/11/2022: Further clinical data for COVID-19 medicine published

The clinical data for Spikevax support its extension of indication to include use in children aged 6 months to 5 years. More information is available on the EMA corporate website.

10/11/2022: Further clinical data for COVID-19 medicine published

The clinical data for Nuvaxovid support its extension of indication to include use in adolescents aged 12 to 17. More information is available on the EMA corporate website.

09/11/2022: Further clinical data for COVID-19 medicine published

The clinical data refer to the occurrence of myocarditis in children aged 5 to 11, and to the risk of myocarditis after a third dose of Comirnaty. More information is available on the EMA corporate website.

09/11/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data supporting the use of Nuvaxovid as a booster dose for adults who have received the same or another COVID-19 vaccine for their initial vaccination. More information is available on the EMA corporate website.

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

The clinical data for Spikevax support the possibility of administering this vaccine together with a dose of the QIV-HD flu vaccine. More information is available on the EMA corporate website.

28/10/2022: Further clinical data for COVID-19 medicine published

The clinical data for Comirnaty support the authorisation of its adapted bivalent version Original/Omicron BA.1 sub-variant. More information is available on the EMA corporate website.

25/10/2022: Further clinical data for COVID-19 medicine published

EMA published clinical data supporting the use of Comirnaty as a booster dose for children aged 5 to 11. More information is available on the EMA corporate website.

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

Latest clinical data published

COVID-19 Vaccine (inactivated, adjuvanted) Valneva (SARS-CoV-2 virus, strain Wuhan hCoV-19/Italy/INMI1-isl/2020, Inactivated) EMEA/H/C/006019/0000 published 26 January 2023

Veklury (Remdesivir) EMEA/H/C/005622/II/0043 published 26 January 2023

COMIRNATY (Tozinameran) EMEA/H/C/005735/X/0147 published 23 January 2023

SPIKEVAX (Elasomeran) EMEA/H/C/005791/II/0075/G published 21 December 2022

JCOVDEN (COVID-19 vaccine (Ad26.COV2-S [recombinant])) EMEA/H/C/005737/II/0060 published 21 December 2022

VAXZEVRIA (COVID 19 Vaccine (ChAdOx1 S [recombinant])) EMEA/H/C/005675/II/0038 published 29 November 2022

Veklury (Remdesivir) EMEA/H/C/005622/II/0037/G published 29 November 2022

COMIRNATY (Tozinameran) EMEA/H/C/005735/II/0143 published 23 November 2022

Veklury (Remdesivir) EMEA/H/C/005622/II/0035/G published 22 November 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/II/0008 published 18 November 2022

 

 

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