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.

22/07/2021: 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

19/03/2021: Clinical data for withdrawn application for dexamethasone for COVID-19 published

The clinical data for Dexamethasone Taw correspond to the withdrawn marketing authorisation application for treating hospitalised adult patients with COVID-19 and several inflammatory conditions or conditions where the immune system is overactive. Further information on this withdrawn application is available on the EMA corporate website.

11/03/2021: Clinical data for new COVID-19 medicine published

Comirnaty is a vaccine for preventing coronavirus disease (COVID-19) in people aged 16 years and older. EMA has published the clinical data supporting the granting of a conditional marketing authorisation. These include interim results from an ongoing clinical trial containing temporary redactions to protect the blinded nature of the study, as explained in the Anonymisation Report. EMA will publish updated documents with fewer redactions following the study unblinding and participant safety narratives by the end of June 2021. Further information on this medicine is available on the EMA corporate website

02/03/2021: Clinical data for new COVID-19 medicine published

COVID-19 Vaccine Moderna 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

25/02/2021: Clinical data for an existing COVID-19 medicine published

The clinical data for Veklury (remdesivir) correspond to a variation to the marketing authorisation updating the indication to specify patients requiring low- or high-flow oxygen or other non-invasive ventilation at start of treatment. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

Latest clinical data published

COMIRNATY (COVID-19 mRNA vaccine (nucleoside-modified)) EMEA/H/C/005735/0000 published 22 July 2021

Dexamethasone Taw (WD) (DEXAMETHASONE PHOSPHATE) EMEA/H/C/005740/0000 published 19 March 2021

COVID-19 Vaccine Moderna (COVID-19 mRNA vaccine (nucleoside-modified)) EMEA/H/C/005791/0000 published 2 March 2021

Veklury (REMDESIVIR) EMEA/H/C/005622/0000/II/0012 published 25 February 2021

Veklury (REMDESIVIR) EMEA/H/C/005622/0000 published 30 October 2020

Inovelon (RUFINAMIDE) EMEA/H/C/000660/II/0037 published 4 December 2018

Ameluz (5-AMINOLEVULINIC ACID) EMEA/H/C/002204/II/0020 published 12 November 2018

Truxima (RITUXIMAB) EMEA/H/C/004112/0000 published 9 November 2018

Alecensa (ALECTINIB) EMEA/H/C/004164/0000 published 17 October 2018

Lucentis (RANIBIZUMAB) EMEA/H/C/000715/II/0061 published 9 October 2018

 

 

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Firstly, users register for an EMA account.

Secondly, users create a log in on this website to have access to the data published.

Without an EMA account access to the Clinical Data publication web site will not activate.

Please go to the EMA account registration site by clicking the register button. When you have created your EMA account, please return to this website, Clinical Data publication. On this website you will then need to create your log in to access the published data.