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 EMA and its policy on the publication of clinical data, see the EMA corporate website.
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.
16/04/2021: Clinical data website intermittently unavailable 16 to 18 April 2021
This website will be intermittently unavailable from 18:00 on Friday 16 April to 11:00 on Sunday 18 April 2021 (CEST), due to essential maintenance. For further information, please use the EMA Service Desk portal.
19/03/2021: Clinical data for withdrawn application for dexamethasone for COVID-19 published
The clinical data for Dexamethasone Taw correspond to the withdrawn marketing authorisation application for treating hospitalised adult patients with COVID-19 and several inflammatory conditions or conditions where the immune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 Further information on this withdrawn application is available on the EMA corporate website.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 2019 (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.
30/10/2020: Clinical data for new COVID-19 medicine published
Veklury (remdesivir) is an antiviral medicine used to treat coronavirus disease 2019 (COVID-19). It is used in adults and adolescents with pneumonia requiring supplemental oxygen. Further information on this medicine is available on the EMA corporate website.
20/12/2018: Temporary suspension of clinical data publication
EMA has temporarily suspended the publication of clinical data until further notice, as a result of the implementation of the third phase of its business continuity plan to help prepare for its relocation to the Netherlands.
(REMDESIVIR) EMEA/H/C/005622/0000/II/0012 published 25 February 2021
(REMDESIVIR) EMEA/H/C/005622/0000 published 30 October 2020
(RUFINAMIDE) EMEA/H/C/000660/II/0037 published 4 December 2018
(5-AMINOLEVULINIC ACID) EMEA/H/C/002204/II/0020 published 12 November 2018
(RITUXIMAB) EMEA/H/C/004112/0000 published 9 November 2018
(ALECTINIB) EMEA/H/C/004164/0000 published 17 October 2018
(RANIBIZUMAB) EMEA/H/C/000715/II/0061 published 9 October 2018
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