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

17/10/18: Clinical data for new medicine published

Alecensa is used as monotherapy to treat adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer previously treated with crizotinib. Further information on this medicine is available on the EMA corporate website.

12/10/18: Clinical data for new medicine published

The clinical data for Lucentis correspond to a variation to the marketing authorisation to include treatment of visual impairment due to choroidal neovascularization based on data from the MINERVA study. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

02/10/18: Clinical data for two new medicines published

Movymia is a biosimilar medicine used to treat osteoporosis in postmenopausal women and in men at increased risk of bone fracture, and osteoporosis associated with sustained systemic glucocorticoid therapy in men and women at increased risk of bone fracture. Further information on this medicine is available on the EMA corporate website.

Terrosa is a biosimilar medicine used to treat osteoporosis in postmenopausal women and in men at increased risk of bone fracture, and osteoporosis associated with sustained systemic glucocorticoid therapy in men and women at increased risk of bone fracture. Further information on this medicine is available on the EMA corporate website.

01/10/18: Clinical data for new medicine published

The clinical data for Jardiance correspond to a variation to the marketing authorisation to reword the indication and sections 4.4, 4.5 and 5.1 of the Summary of Product characteristics (SPC) to reflect new data on cardiovascular outcomes from the phase III EMPA-REG OUTCOME clinical trial. Further information on this variation to the marketing authorisation is available on the EMA corporate website.

28/09/18: Clinical data for new medicine published

Ledaga is used for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma in adult patients. Further information on this medicine is available on the EMA corporate website.

27/09/18: Clinical data for new medicine published

Ivabradine Accord is used to treat chronic stable angina pectoris in coronary artery disease in adults with normal sinus rhythm, heart rate ≥ 70 bpm and with a contra-indication to beta-blockers, or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose. It is also used in chronic heart failure (NYHA II to IV class) with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated. Further information on this medicine is available on the EMA corporate website.

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 Mylan, 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.

 

 

Latest clinical data published

Alecensa (ALECTINIB) EMEA/H/C/004164/0000 published 17 October 2018

Lucentis (RANIBIZUMAB) EMEA/H/C/000715/II/0061 published 9 October 2018

Movymia (TERIPARATIDE) EMEA/H/C/004368/0000 published 2 October 2018

Terrosa (TERIPARATIDE) EMEA/H/C/003916/0000 published 2 October 2018

Jardiance (EMPAGLIFLOZIN) EMEA/H/C/002677/II/0014 published 1 October 2018

LEDAGA (CHLORMETHINE) EMEA/H/C/002826/0000 published 28 September 2018

Ivabradine Accord (IVABRADINE) EMEA/H/C/004241/0000 published 27 September 2018

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