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

13/09/17: Clinical data for new medicine published

The clinical data for Docetaxel SUN correspond to a withdrawn application for a marketing authorisation for a generic product to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma and cancer of the head and neck.

12/09/17: Clinical data for new medicine published

The clinical data for HyQvia correspond to a variation to the marketing authorisation to extend the existing indication to include paediatric population for all authorised indications, and to reflect the results of paediatric studies in the summary of product characteristics.

07/09/17: Clinical data for new medicine published

The clinical data for Kyprolis correspond to a variation to the marketing authorisation to extend the existing indication to include the treatment with dexamethasone alone of adult patients with multiple myeloma who have received at least one prior therapy.

05/09/17: Clinical data for new medicine published

Zepatier is indicated for the treatment of chronic hepatitis C (CHC) in adults.

04/09/17: Clinical data for new medicine published

Darzalex is an orphan medicine used to treat adults with multiple myeloma. It is used either on its own or in combination with dexamethasone plus either lenalidomide or bortezomib.

01/09/17: Clinical data for new medicine published

The clinical data for Afinitor correspond to a variation to the marketing authorisation to extend the existing indication to include the treatment of unresectable or metastatic, well-differentiated non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

25/08/17: Clinical data for new medicine published

Bortezomib Sun is a generic medicine used to treat multiple myeloma, as monotherapy or in combination with other medicines. It is also indicated to treat previously untreated mantle cell lymphoma, in combination with other medicines.

10/08/17: Clinical data for two new medicines published

The clinical data for Ruconest correspond to a variation to the marketing authorisation to extend the existing indication to include the treatment of acute angioedema attacks in adolescents with hereditary angioedema due to C1 esterase inhibitor deficiency.

The clinical data for Gazyvaro correspond to a variation to the marketing authorisation to extend the existing indication to treat adult patients with follicular lymphoma who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. It is used in combination with bendamustine.

02/08/17: Clinical data for two new medicines published

Taltz is used for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

The clinical data for Victoza correspond to a variation to the marketing authorisation to extend the existing indication to monotherapy when diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate. Additionally, the clinical data include information related to the use of Victoza in patients with hepatic and renal impairment.

Latest clinical data published

Qtern (SAXAGLIPTIN / DAPAGLIFLOZIN) published 20 September 2017

OPDIVO (NIVOLUMAB) published 19 September 2017

Docetaxel SUN (DOCETAXEL) published 13 September 2017

HyQvia (HUMAN NORMAL IMMUNOGLOBULIN) published 12 September 2017

Kyprolis (CARFILZOMIB) published 7 September 2017

Zepatier (ELBASVIR / GRAZOPREVIR) published 5 September 2017

Darzalex (DARATUMUMAB) published 4 September 2017

Afinitor (EVEROLIMUS) published 1 September 2017

Bortezomib SUN (BORTEZOMIB) published 25 August 2017

Ruconest (CONESTAT ALFA) published 10 August 2017