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

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

Pregabalin Zentiva k.s. is used to treat peripheral and central neuropathic pain, partial seizures with or without secondary generalisation as adjunctive therapy, and generalised anxiety disorder in adults. Further information on this medicine is available on the EMA corporate website.

The clinical data for Kepnetic correspond to a withdrawn application for a marketing authorisation for a medicine to treat adults with GNE myopathy, an inherited muscle-wasting disease. Further information on this withdrawn marketing authorisation application is available on the EMA corporate website.

17/09/18: Clinical data for two new medicines published

The clinical data for Keytruda correspond to a variation to the marketing authorisation to include first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a ≥50% tumour proportion score with no EGFR or ALK positive tumour mutations. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

Darunavir, co-administered with low dose ritonavir, is used in combination with other antiretroviral medicinal products to treat human immunodeficiency virus infection in antiretroviral treatment (ART)-experienced adults, including those who have been highly pre-treated, and in paediatric patients from the age of 3 years and at least 15 kg body weight. Further information on this medicine is available on the EMA corporate website.

14/09/18: Clinical data for new medicine published

The clinical data for Humira correspond to a variation to the marketing authorisation to include treatment of adolescents from 12 years of age with hidradenitis suppurativa. Further information on this variation to the marketing authorisation is available on the EMA corporate website.   

12/09/18: Clinical data for new medicine published

Ocaliva is used to treat adults with primary biliary cholangitis. Further information on this medicine is available on the EMA corporate website.

05/09/18: Clinical data for new medicine published

Lusduna is used to treat diabetes mellitus in adults, adolescents and children from the age of two. Further information on this medicine is available on the EMA corporate website.

03/09/18: Clinical data for new medicine published

The clinical data for Vimpat correspond to a variation to the marketing authorisation to include monotherapy treatment of partial-onset seizures with or without secondary generalisation in adult and adolescent (16-18 years) patients with epilepsy. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

30/08/18: Clinical data for new medicine published

Afstyla is used for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) of all age groups. Further information on this medicine is available on the EMA corporate website.

29/08/18: Clinical data for new medicine published

The clinical data for Nimenrix correspond to a variation to the marketing authorisation to extend the paediatric population by lowering the age for the active immunisation against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y to 6 weeks. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

 

Latest clinical data published

Pregabalin Zentiva k.s. (PREGABALIN) EMEA/H/C/004277/0000 published 18 September 2018

Kepnetic (WD) (ACENEURAMIC ACID) EMEA/H/C/004176/0000 published 18 September 2018

Keytruda (PEMBROLIZUMAB) EMEA/H/C/003820/II/0011 published 14 September 2018

Darunavir Mylan (DARUNAVIR) EMEA/H/C/004068/0000 published 13 September 2018

Humira (ADALIMUMAB) EMEA/H/C/000481/II/0154 published 13 September 2018

OCALIVA (OBETICHOLIC ACID) EMEA/H/C/004093/0000 published 12 September 2018

LUSDUNA (INSULIN GLARGINE) EMEA/H/C/004101/0000 published 5 September 2018

Vimpat (LACOSAMIDE) EMEA/H/C/000863/II/0060/G published 3 September 2018

Afstyla (LONOCTOCOG ALFA) EMEA/H/C/004075/0000 published 30 August 2018

Nimenrix (MENINGOCOCCAL GROUP A, C, W135 AND Y CONJUGATE VACCINE) EMEA/H/C/002226/II/0049 published 29 August 2018