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 has resumed clinical data publication for medicines with new active substances that received a CHMP opinion from September 2023 onwards, or were withdrawn before the opinion stage. EMA continues publishing clinical data for COVID-19 medicines. More information is available on EMA's corporate website.  

06/02/2024: Clinical data published 

The clinical data refer to Veoza (Fezolinetant), a medicine indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. More information is available on the Veoza medicine on EMA's corporate website.

06/02/2024: Further clinical data for COVID-19 medicine published

The clinical data refer to Skycovion, a COVID-19 vaccine whose application for marketing authorisation was withdrawn. More information is available on the Skycovion medicine on EMA's corporate website.

06/02/2024: Clinical data published 

The clinical data refer to Rezzayo (Rezafungin), an antifungal medicine indicated for the treatment of invasive candidiasis in adults. More information is available on the Rezzayo medicine on EMA's corporate website.

02/02/2024: Clinical data published

The clinical data refer to the initial marketing authorisation application for Ebglyss, for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy. More information is available on the Ebglyss medicine page on EMA's corporate website

29/01/2024: Clinical data published:

The clinical data refer to the initial marketing authorisation application for Zilbrysq, an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti acetylcholine receptor (AChR) antibody positive. More information is available on the Zilbrysq medicine page on EMA's corporate website.

25/01/2024: Clinical data published:

The clinical data refer to the initial marketing authorisation application for Yorvipath, a parathyroid hormone replacement therapy for the treatment of adults with chronic hypoparathyroidism. More information is available on the EMA corporate website.

18/01/2024: Further clinical data for COVID-19 medicine published:

The clinical data refer to a final report from a study evaluating the safety and immunogenicity of Bimervax in healthy adults. More information is available on the EMA corporate website.

18/01/2024: Further clinical data for COVID-19 medicine published:

The clinical data refer to Lagevrio, a COVID-19 treatment whose application for marketing authorisation was withdrawn. More information is available on the EMA corporate website.

17/01/2024: Further clinical data for COVID-19 medicine published:

The clinical data includes the final results from the studies TACKLE (D8851C00001) PROVENT (D8850C00002) and STORM CHASER (D8850C00003) for Evusheld which support its use as a treatment in people aged 12 years and over who weigh at least 40 kg, do not require supplemental oxygen and who are at risk of severe COVID-19. More information is available on the EMA corporate website.

19/12/2023: Further clinical data for COVID-19 medicine published:

The clinical data for Comirnaty refer to a final report from a study on the safety and immunogenicity of this COVID-19 vaccine using different doses in healthy and immunocompromised adults. More information is available on the EMA corporate website.

19/12/2023: Further clinical data for COVID-19 medicine published:

The clinical data for Jcovden refer to a final study report (VAC31518COV2001) evaluating a range of dose levels and vaccination intervals of this COVID-19 vaccine in healthy adults. More information is available on the EMA corporate website.

10/11/2023: Further clinical data for COVID-19 medicine published:

The clinical data for Veklury address the safety of this COVID-19 treatment in patients with hepatic impairment. More information is available on the EMA corporate website.

19/09/2023: Further clinical data for COVID-19 medicine published:

The clinical data for Comirnaty support an extension of indication to include a new strength of this COVID-19 vaccine for use in children aged 6 months to 4 years. They also support the use of its adapted BA.4-5 version as a primary vaccination course in people aged 5 years and over. More information is available on the EMA corporate website.

14/09/2023: Further clinical data for COVID-19 medicine published:

The clinical data for Spikevax support the extension of indication to include use of its adapted BA.4-5 version as a two-dose primary vaccination course in children aged 6 months to 5 years and as a single-dose primary vaccination course, irrespective of vaccination history, in children aged 6 years and over. More information is available on the EMA corporate website.

Latest clinical data published

Veoza (Fezolinetant) EMEA/H/C/005851/0000 published 6 February 2024

SKYCovion (WD) (GBP510) EMEA/H/C/005998/0000 published 6 February 2024

Rezzayo (Rezafungin) EMEA/H/C/005900/0000 published 6 February 2024

Ebglyss (Lebrikizumab) EMEA/H/C/005894/0000 published 2 February 2024

ZILBRYSQ (Zilucoplan) EMEA/H/C/005450/0000 published 29 January 2024

Yorvipath (Palopegteriparatide) EMEA/H/C/005934/0000 published 26 January 2024

BIMERVAX (SARS-CoV-2 virus, variants B.1.351-B.1.1.7, spike protein, receptor binding domain fusion heterodimer) EMEA/H/C/006058/II/0002 published 18 January 2024

Lagevrio (Molnupiravir) EMEA/H/C/005789/0000 published 18 January 2024

EVUSHELD (Tixagevimab/Cilgavimab) EMEA/H/C/005788/II/0009/G published 17 January 2024

BIMERVAX (SARS-CoV-2 virus, variants B.1.351-B.1.1.7, spike protein, receptor binding domain fusion heterodimer) EMEA/H/C/006058/II/0008 published 20 December 2023

 

 

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