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

16/08/18: Temporary suspension of clinical data publication

As of 1 August 2018 EMA is not processing new clinical dossiers for publication. This is a result of the implementation of the third phase of EMA's business continuity plan to prepare for its relocation to the Netherlands.

EMA will continue to publish clinical data received before 1 August 2018 but no new clinical data packages will be processed until further notice.

16/08/18: Clinical data for new medicine published

Olumiant is used as monotherapy or in combination with methotrexate to treat moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. Further information on this medicine is available on the EMA corporate website.

07/08/18: Clinical data for new medicine published

The clinical data for Cynrize correspond to an extension of the marketing authorisation to include the treatment and pre-procedure prevention of angioedema attacks in children with hereditary angioedema from the age of two, and the routine prevention of angioedema attacks from the age of six. Further information on this variation is available on the EMA corporate website.

03/08/18: Clinical data for new medicine published

The clinical data for Stelara correspond to an extension of the marketing authorisation to treat adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies. Further information on this line extension is available on the EMA corporate website.

02/08/18: Clinical data for new medicine published

The clinical data for Repatha correspond to an extension of the marketing authorisation for a new 420mg solution for injection cartridge, corresponding to an already approved 420 mg dose. Further information on this line extension is available on the EMA corporate website.

30/07/18: Clinical data for new medicine published

Ibrance is used to treat hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor, or in combination with fulvestrant in women who have received prior endocrine therapy. Further information on this medicine is available on the EMA corporate website.

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

Vemlidy is used to treat chronic hepatitis B in adults and adolescents aged 12 years and older with body weight of at least 35 kg. Further information on this medicine is available on the EMA corporate website.

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.

 

 

Latest clinical data published

Olumiant (BARICITINIB) EMEA/H/C/004085/0000 published 14 August 2018

Cinryze (C1 ESTERASE INHIBITOR (HUMAN)) EMEA/H/C/001207/II/0045 published 7 August 2018

Stelara (USTEKINUMAB) EMEA/H/C/000958/X/0049/G published 3 August 2018

Repatha (EVOLOCUMAB) EMEA/H/C/003766/X/0002 published 2 August 2018

IBRANCE (PALBOCICLIB) EMEA/H/C/003853/0000 published 27 July 2018

Vemlidy (TENOFOVIR ALAFENAMIDE) EMEA/H/C/004169/0000 published 26 July 2018

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