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

24/07/17: Clinical data for new medicine published

The clinical data for Avastin correspond to a variation to the marketing authorisation to extend the existing indication to the treatment of unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations in combination with erlotinib.

Pandemic influenza vaccine H5N1 AstraZeneca is used to protect children aged between 12 months and 18 years against influenza (flu) during a flu pandemic. It has a conditional marketing authorisation.

18/07/17: Clinical data for new medicine published

Zinbryta is used to treat adults with the relapsing forms of multiple sclerosis.

07/07/17: Clinical data for new medicine published

Lonsurf is a cancer medicine used to treat adults with metastatic colorectal cancer who have already been treated with, or who cannot be given, other available treatments.

03/07/17: Clinical data for new medicines published

Flixabi is an anti-inflammatory used when other medicines or treatments have failed or cannot be used for the treatment of the following diseases: rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

Flixabi is a biosimilar medicine, meaning it is a biological medicine highly similar to another biological medicine already approved in the EU (Remicade).

Strimvelis is a gene therapy product used to treat patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), for whom no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available.

Halaven is used to treat a subset of patients with locally advanced or metastatic breast cancer and patients with unresectable liposarcoma.

Latest clinical data published

Avastin (BEVACIZUMAB) published 24 July 2017

Pandemic influenza vaccine H5N1 AstraZeneca (PANDEMIC INFLUENZA VACCINE (H5N1) (LIVE ATTENUATED, NASAL)) published 21 July 2017

Zinbryta (DACLIZUMAB) published 17 July 2017

Lonsurf (TRIFLURIDINE / TIPIRACIL) published 7 July 2017

Flixabi (INFLIXIMAB) published 30 June 2017

Strimvelis (AUTOLOGOUS CD34+ ENRICHED CELL FRACTION THAT CONTAINS CD34+ CELLS TRANSDUCED WITH RETROVIRAL VECTOR THAT ENCODES FOR THE HUMAN ADA CDNA SEQUENCE) published 29 June 2017

Halaven (ERIBULIN) published 22 June 2017

OPDIVO (NIVOLUMAB) published 21 June 2017

OPDIVO (NIVOLUMAB) published 21 June 2017

Bortezomib Hospira (BORTEZOMIB) published 12 June 2017

 

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