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

12/01/18: Clinical data for new medicine published

The clinical data for Nevanac correspond to a variation to the marketing authorisation to include treatment of adult diabetic patients to reduce the risk of postoperative macular oedema associated with cataract surgery. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

05/01/18: Clinical data for new medicine published

Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

20/12/17: Clinical data for new medicine published

The clinical data for Ilaris correspond to a variation to the marketing authorisation to amend the systemic juvenile idiopathic arthritis indication to include treatment of active Still’s disease including adult-onset Still’s disease in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs and systemic corticosteroids. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

19/12/17: Clinical data for new medicine published

The clinical data for Zontivity correspond to a variation to the marketing authorisation to extend the existing indication to include treatment of patients with symptomatic peripheral arterial disease. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

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.

Latest clinical data published

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

Nevanac (NEPAFENAC) EMEA/H/C/000818/II/0032 published 12 January 2018

Truberzi (ELUXADOLINE) EMEA/H/C/004098/0000 published 5 January 2018

ILARIS (CANAKINUMAB) EMEA/H/C/001109/II/0043 published 20 December 2017

Zontivity (VORAPAXAR) EMEA/H/C/002814/II/0005 published 19 December 2017

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