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publication for medicines with new active substances that received a CHMP opinion from September 2023 onwards, or were withdrawn before the opinion stage.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.

15/03/2024: Further clinical data for COVID-19 medicine published

The clinical data support a modified dosage for COVID-19 vaccine Nuvaxovid boosters meant for adolescents, based on interim results from a study evaluating efficacy, safety and immunogenicity. More information is available on the Nuvaxovid page on EMA's corporate website.

14/03/2024: Further clinical data for COVID-19 medicine published 

The clinical data refer to a study report assessing the immunogenicity, safety and tolerability of administering COVID-19 medicine Ronapreve (casirivimab / imdevimab) together with the Moderna mRNA-1273 vaccine in healthy adults. More information is available on the Ronapreve page on EMA's corporate website.

14/03/2024: Clinical data published

The clinical data refer to Elucirem (gadopiclenol), a contrast agent to improve images obtained through magnetic resonance imaging (MRI). It is used for the diagnosis in adults and children 2 years and older of pathologies with disruption of the blood brain barrier (BBB) or abnormal vascularity of other organs. More information is available on EMA's corporate website.

11/03/2024: Clinical data published

The clinical data refer to Krazati (Adagrasib) a medicine indicated as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC). More information is available on EMA's corporate website.

07/03/2024: Clinical data published

The clinical data refer to Jivadco (Trastuzumab duocarmazine) a medicine indicated as monotherapy for the treatment of adult patients with HER-2 positive metastatic breast cancer. More information is available on EMA's corporate website.

07/03/2024: Further clinical for COVID-19 medicine published

The clinical data support a modified composition for COVID-19 vaccine Nuvaxovid, introducing a new variant strain (XBB.1.5) with an updated posology regimen and recommendations, and updated safety and efficacy information, based on study results.

07/03/2024: Further clinical data for COVID-19 medicine published

The clinical data refer to several clinical studies supporting updates of efficacy, safety, and pharmacokinetic information for Paxlovid (nirmatrelvir / ritonavir). More information is available on the Paxlovid page on EMA's corporate website.

28/02/2024: Clinical data published for COVID-19 medicine published

The clinical data refer to a final report from a study evaluating the safety and immunogenicity of COVID-19 vaccine Bimervax in healthy adults. More information is available on the Bimervax medicine page on EMA's corporate website.

22/02/2024: Clinical data published 

The clinical data refer to Elrexfio (elranatamab), a medicine indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma. More information is available on the Elrexfio medicine 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.

Latest clinical data published

Nuvaxovid (COVID-19 vaccine (recombinant, adjuvanted)) EMEA/H/C/005808/II/0045 published 15 March 2024

RONAPREVE (Casirivimab/Imdevimab) EMEA/H/C/005814/II/0014 published 14 March 2024

Elucirem (Gadopiclenol) EMEA/H/C/005626/0000 published 14 March 2024

Krazati (Adagrasib) EMEA/H/C/006013/0000 published 11 March 2024

Jivadco (WD) (Trastuzumab duocarmazine) EMEA/H/C/005654/0000 published 7 March 2024

Nuvaxovid (COVID-19 vaccine (recombinant, adjuvanted)) EMEA/H/C/005808/II/0058/G published 7 March 2024

Paxlovid (Nirmatrelvir/Ritonavir) EMEA/H/C/005973/II/0042 published 7 March 2024

BIMERVAX (PHH-1V81 / Selvacovatein) EMEA/H/C/006058/II/0006 published 28 February 2024

ELREXFIO (Elranatamab) EMEA/H/C/005908/0000 published 22 February 2024

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

 

 

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