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

18/05/18: Clinical data for two new medicines published

Ivabradine Zentiva is a generic medicine used in the symptomatic treatment of chronic stable angina in certain patients with coronary artery disease. It is also used in a certain patients with chronic heart failure. Further information on this medicine is available on the EMA corporate website.

The clinical data for Adempas correspond to a withdrawn variation to the marketing authorisation to include treatment of adults with pulmonary arterial hypertension associated with congenital heart disease. Further information on this withdrawn variation to the marketing authorisation is available on the EMA corporate website.

17/05/18: Clinical data for new medicine published

The clinical data for Zytiga correspond to an extension of the marketing authorisation to include treatment with prednisone or prednisolone of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated, and in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. Further information on this extension of the marketing authorisation is available on the EMA corporate website.

08/05/18: Clinical data for new medicine published

Onivyde is used in the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and leucovorin, in adult patients who have progressed following gemcitabine based therapy. Further information on this medicine is available on the EMA corporate website.

25/04/18: Clinical data for new medicine published

Grandipam is a generic medicine used as in the treatment of adults with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. It is also used to treat children aged 1 - 17 years old with pulmonary arterial hypertension. Further information on this medicine is available on the EMA corporate website.

19/04/18: Clinical data for new medicine published

The clinical data for Humira correspond to a variation to the marketing authorisation to include treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

17/04/18: Clinical data for new medicine published

CINQAERO is used as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Further information on this medicine is available on the EMA corporate website.

11/04/18: Clinical data for new medicine published

The clinical data for Imbruvica correspond to a variation to the marketing authorisation to include treatment of chronic lymphocytic leukaemia in combination with bendamustine and rituximab in patients who have received at least one prior therapy. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

06/04/18: Clinical data for new medicine published

Ivabradine JensonR is a generic medicine used in the symptomatic treatment of chronic stable angina pectoris and in the treatment of chronic heart failure in patients, either when beta-blockers are contraindicated or when the condition is inadequately controlled with an optimal beta-blocker dose. Further information on this medicine is available on the EMA corporate website.

26/03/18: Clinical data for new medicine published

The clinical data for Xalkori correspond to a variation to the marketing authorisation to include treatment of adults with anaplastic lymphoma kinase (ALK)-positive and ROS1-positive advanced non-small cell lung cancer. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

Latest clinical data published

Parsabiv (ETELCALCETIDE) EMEA/H/C/003995/0000 published 18 May 2018

Adempas (RIOCIGUAT) EMEA/H/C/002737/II/0011 published 18 May 2018

Ivabradine Zentiva (IVABRADINE) EMEA/H/C/004117/0000 published 18 May 2018

Zytiga (ABIRATERONE ACETATE) EMEA/H/C/002321/X/0039 published 17 May 2018

Onivyde (IRINOTECAN HYDROCHLORIDE TRIHYDRATE) EMEA/H/C/004125/0000 published 8 May 2018

Granpidam (SILDENAFIL) EMEA/H/C/004289/0000 published 25 April 2018

Humira (ADALIMUMAB) EMEA/H/C/000481/II/0146 published 19 April 2018

Cinqaero (RESLIZUMAB) EMEA/H/C/003912/0000 published 17 April 2018

Imbruvica (IBRUTINIB) EMEA/H/C/003791/II/0017/G published 11 April 2018

Ivabradine JensonR (IVABRADINE) EMEA/H/C/004217/0000 published 6 April 2018