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.

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.

4/12/2018: Clinical data for new medicine published

The clinical data for Inovelon correspond to a variation to the marketing authorisation to update sections 4.2, 4.8, 5.1, 5.2 and 5.3 of the summary of product characteristics with the key findings of a study in children aged 1 - 4 years with Lennox-Gastaut syndrome and of toxicity studies in juvenile animals. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

12/11/2018: Clinical data for new medicine published

The clinical data for Ameluz correspond to a variation to the marketing authorisation to include treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

Latest clinical data published

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

Movymia (TERIPARATIDE) EMEA/H/C/004368/0000 published 2 October 2018

Terrosa (TERIPARATIDE) EMEA/H/C/003916/0000 published 2 October 2018

Jardiance (EMPAGLIFLOZIN) EMEA/H/C/002677/II/0014 published 1 October 2018

 

 

Registration

Registration is a two-step process.

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.