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publication for medicines with new active substances that received a CHMP opinion from September 2023 onwards, or were withdrawn before the opinion stage.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

13/06/2024: Clinical data published

The clinical data refer to Exblifep (cefepime / enmetazobactam), a medicine indicated for the treatment in adults of infections such as complicated urinary tract infections and hospital-acquired pneumonia. More information on Exblifep is available on EMA’s corporate website.

13/06/2024: Clinical data published

The clinical data refer to Velsipity (etrasimod), a medicine indicated for the treatment of moderately to severely active ulcerative colitis in patients aged 16 years and older. More information on Velsipity is available on EMA’s corporate website.

06/06/2024: Clinical data published

The clinical data refer to Tizveni (tislelizumab), indicated in the treatment of adult patients with locally or metastatic non-small cell lung cancer (NSCLC). More information on Tizveni is available on EMA's corporate website.

06/06/2024: Clinical data published

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

30/05/2024: Further clinical data for COVID-19 medicine published

The clinical data on COVID-19 vaccine Spikevax refer to a final report from a study evaluating the efficacy, safety and immunogenicity of its mRNA-1273 booster in adults. More information on Spikevax is available on EMA's corporate website.

30/05/2024: Clinical data published

The clinical data refer to Zynyz (retifanlimab), an orphan medicine used in adults to treat Merkel cell carcinoma (a type of skin cancer) that cannot be cured by surgery or radiation therapy. More information on Zynyz is available on EMA's corporate website.

30/05/2024: Clinical data published

The clinical data refer to Skyclarys (omaveloxolone), an orphan medicine indicated for the treatment of Friedreichs ataxia in patients aged 16 years and older. More information on Skyclarys is available on EMA's corporate website.

16/05/2024: Clinical data published

The clinical data refer to Casgevy (exagamglogene autotemcel), an orphan medicine used to treat blood disorders known as beta thalassaemia and sickle cell disease in patients aged 12 and older. More information on Casgevy is available on EMA's corporate website.

26/04/2024: Further clinical data for COVID-19 medicine published

The clinical data for COVID-19 vaccine Vaxzevria support a safety and efficacy update on adverse drug reactions frequency. This is based on final analysis from studies including COV001, COV002, COV003 and COV005. More information on Vaxzevria is available on EMA's corporate website.

17/04/2024: Clinical data published

The clinical data refer to Vanflyta (quizartinib), a medicine indicated for adult patients with newly diagnosed acute myeloid leukaemia (AML) FLT3-ITD positive. More information on Vanflyta is available on EMA's corporate website.

15/04/2024: Further clinical data for COVID-19 medicine published

The clinical data refer to several study reports on COVID-19 medicine Xevudy (sotrovimab), assessing its dosage recommendations, administration instructions, efficacy, pharmacokinetic and safety information. More information on Xevudy is available page on EMA's corporate website.

12/04/2024: Clinical data published

The clinical data refer to Rystiggo (rozanolixizumab), a medicine indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. More information on Rystiggo is available on EMA's corporate website.

02/04/2024: Clinical data published

The clinical data refer to Omjjara (momelotinib), a medicine indicated for the treatment of disease-related splenomegaly (enlarged spleen) or other symptoms in adult patients with moderate to severe anaemia who have one of the following rare diseases: primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. More information on Omjjara is available on EMA's corporate website.

27/03/2024: Clinical data published

The clinical data refer to Agamree (vamorolone), an orphan medicine indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged four and older. More information on Agamree is available on EMA's corporate website.

26/03/2024: Clinical data published

The clinical data refer to Loargys (pegzilarginase), an orphan medicine indicated for the treatment of arginase 1 deficiency (ARG1 D) - also known as hyperargininemia - in adults, adolescents and children aged two and older. More information on Loargys is available on EMA's corporate website

21/03/2024: Clinical data published

The clinical data refer to Vueway (gadopiclenol), a contrast agent to improve images obtained through magnetic resonance imaging (MRI). It is used for the diagnosis in adults and children aged two 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.

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 aged two 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 aged 12 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 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.

Latest clinical data published

Ryzneuta (Efbemalenograstim alfa) EMEA/H/C/005828/0000 published 13 June 2024

EXBLIFEP (Cefepime / Enmetazobactam) EMEA/H/C/005431/0000 published 13 June 2024

VELSIPITY (Etrasimod) EMEA/H/C/006007/0000 published 13 June 2024

Tizveni (Tislelizumab) EMEA/H/C/005542/0000 published 6 June 2024

BIMERVAX (PHH-1V81 / Selvacovatein) EMEA/H/C/006058/II/0010 published 6 June 2024

Spikevax (COVID-19 vaccine (Ad26.COV2-S [recombinant])) EMEA/H/C/005791/II/0120 published 30 May 2024

ZYNYZ (Retifanlimab) EMEA/H/C/006194/0000 published 30 May 2024

Skyclarys (Omaveloxolone) EMEA/H/C/006084/0000 published 30 May 2024

Casgevy (Exagamglogene autotemcel) EMEA/H/C/005763/0000 published 16 May 2024

VAXZEVRIA (COVID 19 Vaccine (ChAdOx1 S [recombinant])) EMEA/H/C/005675/II/0089 published 26 April 2024

 

 

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