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

23/02/18: Clinical data for two new medicines published

Aerivio Spiromax and Airexar Spiromax are indicated for the regular treatment of adult patients with severe asthma where use of a combination product is appropriate. They are also indicated for the symptomatic treatment of a subset of adult patients with Chronic Obstructive Pulmonary Disease. Further information on this medicine is available on the EMA corporate website.

23/02/18: Clinical data for two new medicines published

Kisplyx is indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor-targeted therapy. Further information on this medicine is available on the EMA corporate website.

01/02/18: Clinical data for new medicine published

The clinical data for Orencia correspond to a variation to the marketing authorisation to include treatment in combination with methotrexate of adults with rheumatoid arthritis who have highly active disease not previously treated with methotrexate. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

31/01/18: Clinical data for new medicine published

The clinical data for Ertapenem Hospira correspond to a withdrawn application for a marketing authorisation for a medicine intended to be used in paediatric patients (3 months to 17 years of age) and in adults to treat intra-abdominal infections, community-acquired pneumonia, acute gynaecological infections and diabetic foot infections when caused by bacteria known or very likely to be susceptible to ertapenem, and for the prophylaxis of surgical site infection following elective colorectal surgery.

Further information on this marketing authorisation application is available on the EMA corporate website.

26/01/18: Clinical data for new medicine published

The clinical data for Begedina correspond to a withdrawn application for a marketing authorisation for a medicine intented to treat acute graft-versus-host disease in adults who have had haematopoietic progenitor cell from a donor. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

25/01/18: Clinical data for two new medicines published

The clinical data for Keytruda correspond to a variation to the marketing authorisation to include treatment of locally advanced or metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received approved therapy for these mutations prior to receiving Keytruda. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

The clinical data for Alendronic Acid/Colecalciferol Mylan correspond to a withdrawn application for a marketing authorisation for a generic medicine intented for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. Further information on this withdrawn application is available on the EMA corporate website.

23/01/18: Clinical data for new medicine published

The clinical data for Truvada correspond to a variation to the marketing authorisation to include pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults at high risk. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

19/01/18: Clinical data for new medicine published

Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. Further information on this medicine is available on the EMA corporate website.

Latest clinical data published

Aerivio Spiromax (SALMETEROL / FLUTICASONE PROPIONATE) EMEA/H/C/002752/0000 published 23 February 2018

Airexar Spiromax (SALMETEROL / FLUTICASONE PROPIONATE) EMEA/H/C/004267/0000 published 23 February 2018

Kisplyx (LENVATINIB) EMEA/H/C/004224/0000 published 22 February 2018

Orencia (ABATACEPT) EMEA/H/C/000701/II/0097 published 1 February 2018

Ertapenem Hospira (WD) (ERTAPENEM) EMEA/H/C/004080/0000 published 30 January 2018

Begedina (WD) (BEGELOMAB) EMEA/H/C/004144/0000 published 26 January 2018

Keytruda (PEMBROLIZUMAB) EMEA/H/C/003820/II/0007 published 25 January 2018

Alendronic Acid/Colecalciferol Mylan (WD) (ALENDRONIC ACID / COLECALCIFEROL) EMEA/H/C/004172/0000 published 25 January 2018

Truvada (EMTRICITABINE / TENOFOVIR DISOPROXIL) EMEA/H/C/000594/II/0126 published 23 January 2018

Galafold (MIGALASTAT) EMEA/H/C/004059/0000 published 19 January 2018