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

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.

23/03/18: Clinical data for two new medicines published

Emtricitabine/Tenofovir disoproxil Krka is a generic medicine used in antiretroviral combination therapy for the treatment of HIV-1 infected adults, and in the treatment of HIV-1 infected adolescents from the age of 12 with nucleoside reverse transcriptase inhibitors (NRTIs) resistance or toxicities precluding the use of first line agents. It is also indicated in combination with safer sex practices for pre-exposure prophylaxis (known as PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. Further information on this medicine is available on the EMA corporate website.

Emtricitabine/Tenofovir disoproxil Krka d.d. is a generic medicine used in antiretroviral combination therapy for the treatment of HIV-1 infected adults, and in the treatment of HIV-1 infected adolescents from the age of 12 with nucleoside reverse transcriptase inhibitors (NRTIs) resistance or toxicities precluding the use of first line agents. Further information on this medicine is available on the EMA corporate website.

15/03/18: Clinical data for new medicine published

The clinical data for NovoRapid correspond to a variation to the marketing authorisation to include treatment of diabetes mellitus in children from 1 to 2 years of age. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

13/03/18: Clinical data for new medicine published

Chenodeoxycholic acid Leadiant is an orphan medicine used in the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis) in infants, children and adolescents aged 1 month to 18 years, and adults. Further information on this medicine is available on the EMA corporate website.

09/03/18: Clinical data for two new medicines published

Inhixa is an anticoagulant used in the prophylaxis and treatment of thromboembolism, and in the treatment of acute coronary syndromes. Further information on this medicine is available on the EMA corporate website.

Thorinane is an anticoagulant used in the prophylaxis and treatment of thromboembolism, and in the treatment of acute coronary syndromes. Further information on this medicine is available on the EMA corporate website.

06/03/18: Clinical data for new medicine published

Tenofovir disoproxil Zentiva is a generic medicine for the treatment of HIV-1 in adults and chronic hepatitis. Further information on this medicine is available on the EMA corporate website.

Latest clinical data published

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

XALKORI (CRIZOTINIB) EMEA/H/C/002489/II/0039 published 26 March 2018

Emtricitabine/Tenofovir disoproxil Krka (EMTRICITABINE / TENOFOVIR DISOPROXIL) EMEA/H/C/004215/0000 published 20 March 2018

Emtricitabine/tenofovir disoproxil Krka d.d. (EMTRICITABINE / TENOFOVIR DISOPROXIL) EMEA/H/C/004686/0000 published 20 March 2018

NovoRapid (INSULIN ASPART) EMEA/H/C/000258/II/0112 published 15 March 2018

Chenodeoxycholic acid Leadiant (CHENODEOXYCHOLIC ACID) EMEA/H/C/004061/0000 published 12 March 2018

Inhixa (ENOXAPARIN SODIUM) EMEA/H/C/004264/0000 published 9 March 2018