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

30/10/20: Clinical data for new COVID-19 medicine published

EMA has started publishing clinical data for COVID-19 medicines in line with its exceptional transparency measures for treatments and vaccines for COVID-19.

Clinical data publication for all other centrally authorised products remains suspended until further notice.

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.

20/12/18: 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.

4/12/18: 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.

12/11/18: 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.

09/11/18: Clinical data for new medicine published

Truxima is a biosimilar medicine used in adults to treat of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, and granulomatosis with polyangiitis and microscopic polyangiitis. Further information on this medicine is available on the EMA corporate website.

17/10/18: Clinical data for new medicine published

Alecensa is used as monotherapy to treat adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib. Further information on this medicine is available on the EMA corporate website.

12/10/18: Clinical data for new medicine published

The clinical data for Lucentis correspond to a variation to the marketing authorisation to include treatment of visual impairment due to choroidal neovascularization based on data from the MINERVA study. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

02/10/18: Clinical data for two new medicines published

Movymia is a biosimilar medicine used to treat osteoporosis in postmenopausal women and in men at increased risk of bone fracture, and osteoporosis associated with sustained systemic glucocorticoid therapy in men and women at increased risk of bone fracture. Further information on this medicine is available on the EMA corporate website.

Terrosa is a biosimilar medicine used to treat osteoporosis in postmenopausal women and in men at increased risk of bone fracture, and osteoporosis associated with sustained systemic glucocorticoid therapy in men and women at increased risk of bone fracture. Further information on this medicine is available on the EMA corporate website.

01/10/18: Clinical data for new medicine published

The clinical data for Jardiance correspond to a variation to the marketing authorisation to reword the indication and sections 4.4, 4.5 and 5.1 of the Summary of Product characteristics (SPC) to reflect new data on cardiovascular outcomes from the phase III EMPA-REG OUTCOME clinical trial. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

28/09/18: Clinical data for new medicine published

Ledaga is used for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma in adult patients. Further information on this medicine is available on the EMA corporate website.

Latest clinical data published

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

LEDAGA (CHLORMETHINE) EMEA/H/C/002826/0000 published 28 September 2018

 

 

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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.