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

11/12/17: Clinical data for new medicine published

The clinical data for Trevicta correspond to a line extension, which updated the authorised presentations of this medicine. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

6/12/17: Clinical data for new medicine published

The clinical data for Kyndrisa correspond to a withdrawn marketing authorisation application intended for the treatment of Duchenne muscular dystrophy. Further information on the withdrawn application is available on the EMA corporate website.

15/11/17: Clinical data for new medicine published

The clinical data for Arzerra correspond to a variation to the marketing authorisation to extend the existing indication to include maintenance therapy in chronic lymphocytic leukaemia, which received a negative opinion.

15/11/17: Clinical data for two new medicines published

The clinical data for Ryzodeg correspond to a variation to the marketing authorisation to extend the existing indication to include the treatment of diabetes mellitus in paediatric population from 2 years of age.

The clinical data for RoActemra correspond to a variation to the marketing authorisation to extend the existing indication to include the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

27/10/17: Clinical data for new medicine published

Epclusa is indicated for the treatment of chronic hepatitis C virus infection in adults.

24/10/17: Clinical data for new medicine published

Umbipro (TM) is indicated for prophylaxis of omphalitis in newborn infants. It has been authorised for use in countries outside the European Union under article 58 of regulation (EC) No 726/2004.

23/10/17: EMA marks the 1st year anniversary of clinical data publication with a press release

The press release includes some results of the recent survey on clinical data publication. The Agency will publish the full survey results later this year. We would like to thank everyone who took part in the survey.

23/10/17: Clinical data for new medicine published

The clinical data for Imbruvica correspond to a variation to the marketing authorisation to extend the existing indication to include the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.

18/10/17: The clinical data for Nordimet have been republished because the original ATC code has been replaced with a new one.

06/10/17: Clinical data for new medicine published

Mysildecard is a generic medicine used to treat adults and children with pulmonary arterial hypertension (PAH). In adults, it is used in patients with class II or class III PAH.

Latest clinical data published

Trevicta (PALIPERIDONE) EMEA/H/C/004066/X/0007/G published 11 December 2017

Kyndrisa (WD) (DRISAPERSEN) EMEA/H/C/003846/0000 published 6 December 2017

Arzerra (OFATUMUMAB) EMEA/H/C/001131/II/0041 published 16 November 2017

Ryzodeg (INSULIN HUMAN) EMEA/H/C/002499/II/0017 published 15 November 2017

RoActemra (TOCILIZUMAB) EMEA/H/C/000955/II/0057 published 15 November 2017

Epclusa (SOFOSBUVIR / VELPATASVIR) EMEA/H/C/004210/0000 published 26 October 2017

Umbipro (TM) (CHLORHEXIDINE) EMEA/H/W/003799/0000 published 24 October 2017

Imbruvica (IBRUTINIB) EMEA/H/C/003791/II/0016 published 23 October 2017

Nordimet (METHOTREXATE) EMEA/H/C/003983/0000 published 18 October 2017

Mysildecard (SILDENAFIL) EMEA/H/C/004186/0000 published 6 October 2017