This is a summary of the European public assessment report (EPAR) for Inlyta. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Inlyta.
Inlyta : EPAR - Summary for the public (PDF/75.52 KB)
First published: 13/09/2012
Last updated: 21/08/2015
Inlyta : EPAR - Risk-management-plan summary (PDF/1.67 MB)
First published: 26/06/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Renal Cell
|Anatomical therapeutic chemical (ATC) code||
Pfizer Europe MA EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
22/05/2019 Inlyta - EMEA/H/C/002406 - IB/0025
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Inlyta is indicated for the treatment of adult patients with advanced renal-cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.