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

18/07/18: Clinical data for new medicine published.

Rekovelle is used to control ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle. Further information on this medicine is available on the EMA corporate website.

16/07/18: EMA publishes 1st report on the implementation of the policy on the publication of clinical data.

The report covers one year from the launch of EMA’s clinical data website on 20 October 2016. It lists the 54 regulatory dossiers published and the corresponding 50 medicines, which include orphan, paediatric, biosimilar and generic medicines. 

The report also includes the results of a user survey of the clinical data website.

13/07/18: Clinical data for new medicine published.

Fiasp is used in the treatment of diabetes mellitus in adults. Further information on this medicine is available on the EMA corporate website.

04/07/18: Clinical data for a medicine published

The clinical data published for Trisenox, a cancer medicine, supported an extension of indication to include induction of remission, and consolidation in adult patients with newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia. Further information on this medicine is available on the EMA corporate website.

27/06/18: Clinical data for a medicine published

The clinical data published for Opdivo, a cancer medicine, supported an extension of indication to treat Hodgkin lymphoma. Further information on this medicine is available on the EMA corporate website.

26/06/18: Clinical data for new medicine published

Venclyxto is a medicine for treating a blood cancer known as chronic lymphocytic leukaemia (CLL) when other treatments have failed or are unsuitable. Further information on this medicine is available on the EMA corporate website.

22/06/18: Clinical data for three new medicines published

Zinplava is a a medicine used in adults who have infections due to bacteria called Clostridium difficile that cause severe diarrhoea. Further information on this medicine is available on the EMA corporate website.

The clinical data for Zemfirza correspond to a withdrawn application for a marketing authorisation for a medicine intended to treat women with cancer of the ovaries. Further information on this withdrawn application is available on the EMA corporate website.

Cabometyx is a cancer medicine used to treat adults with advanced renal cell carcinoma (a type of kidney cancer). Further information on this medicine is available on the EMA corporate website.

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.

 

 

Latest clinical data published

Rekovelle (FOLLITROPIN DELTA) EMEA/H/C/003994/0000 published 17 July 2018

Fiasp (INSULIN ASPART) EMEA/H/C/004046/0000 published 13 July 2018

Trisenox (ARSENIC TRIOXIDE) EMEA/H/C/000388/II/0058 published 4 July 2018

OPDIVO (NIVOLUMAB) EMEA/H/C/003985/II/0012 published 27 June 2018

Venclyxto (VENETOCLAX) EMEA/H/C/004106/0000 published 26 June 2018

CABOMETYX (CABOZANTINIB) EMEA/H/C/004163/0000 published 22 June 2018

Zemfirza (WD) (CEDIRANIB) EMEA/H/C/004003/0000 published 22 June 2018

Zinplava (BEZLOTOXUMAB) EMEA/H/C/004136/0000 published 22 June 2018

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

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