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

20/06/18: Clinical data for new medicine published

Talmanco is a generic medicine used in adults for the treatment of pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Further information on this medicine is available on the EMA corporate website.

15/06/18: Clinical data for new medicine published

NINLARO is an orphan medicine used in combination with lenalidomide and dexamethasone in treatment of adults with multiple myeloma who have received at least one prior therapy. Further information on this medicine is available on the EMA corporate website.

13/06/18: Clinical data for new medicine published

Tenofovir disoproxil Mylan is generic medicine used in combination with other antiretroviral medicines for the treatment of some HIV-1 infected adults and some HIV-1 infected adolescents. It is also indicated for the treatment of chronic hepatitis B in some adults and in some adolescents. Further information on this medicine is available on the EMA corporate website.

12/06/18: Clinical data for new medicine published

The clinical data for Pemetrexed ditromethamine Hospira correspond to a withdrawn application for a marketing authorisation for a medicine to treat malignant pleural mesothelioma and advanced non-squamous non-small cell lung cancer. Further information on this withdrawn marketing authorisation application is available on the EMA corporate website.

08/06/18: Clinical data for two new medicines published

Lartruvo is an orphan medicine used in combination with doxorubicin to treat adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin. Further information on this medicine is available on the EMA corporate website.

Emtricitabine/Tenofovir disoproxil Mylan is a generic medicine used in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Further information on this medicine is available on the EMA corporate website.

29/05/18: Clinical data for new medicine published

The clinical data for Daklinza correspond to an extension of the marketing authorisation for a new 90 mg tablet, corresponding to an already approved 90 mg dose.

25/05/18: Clinical data for new medicine published

Emtricitabine/Tenofovir disoproxil Zentiva is an generic medicine used in antiretroviral combination therapy for the treatment of HIV-1 infected adults. It is also used in the treatment of HIV-1 infected adolescents (aged 12 to < 18 years) with resistance to nucleoside reverse transcriptase inhibitors or with toxicities precluding the use of first line agents. Further information on this medicine is available on the EMA corporate website.

24/05/18: Clinical data for two new medicines published

The clinical data for Cokiera correspond to a withdrawn application for a marketing authorisation for a medicine to treat adults with chronic hepatitis C. Further information on this withdrawn marketing authorisation application is available on the EMA corporate website.

SomaKit TOC is an orphan diagnostic used for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression for localising primary tumours and their metastases in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumours. Further information on this diagnostic is available on the EMA corporate website.

Latest clinical data published

Talmanco (TADALAFIL) EMEA/H/C/004297/0000 published 20 June 2018

NINLARO (IXAZOMIB) EMEA/H/C/003844/0000 published 15 June 2018

Tenofovir disoproxil Mylan (TENOFOVIR DISOPROXIL) EMEA/H/C/004049/0000 published 13 June 2018

Pemetrexed ditromethamine Hospira (WD) (PEMETREXED) EMEA/H/C/004306/0000 published 12 June 2018

Lartruvo (OLARATUMAB) EMEA/H/C/004216/0000 published 8 June 2018

Emtricitabine/Tenofovir disoproxil Mylan (EMTRICITABINE / TENOFOVIR DISOPROXIL) EMEA/H/C/004050/0000 published 8 June 2018

Daklinza (DACLATASVIR) EMEA/H/C/003768/X/0013 published 29 May 2018

Emtricitabine/Tenofovir disoproxil Zentiva (EMTRICITABINE / TENOFOVIR DISOPROXIL) EMEA/H/C/004137/0000 published 25 May 2018

Cokiera (WD) (DASABUVIR / OMBITASVIR / PARITAPREVIR / RITONAVIR) EMEA/H/C/004235/0000 published 24 May 2018

SomaKit TOC (EDOTREOTIDE) EMEA/H/C/004140/0000 published 24 May 2018