Overview
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.
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List item
Inlyta : EPAR - Summary for the public (PDF/75.52 KB)
First published: 13/09/2012
Last updated: 21/08/2015
EMA/349932/2012 -
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List item
Inlyta : EPAR - Risk-management-plan summary (PDF/1.67 MB)
First published: 26/06/2019
Authorisation details
Product details | |
---|---|
Name |
Inlyta
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Agency product number |
EMEA/H/C/002406
|
Active substance |
axitinib
|
International non-proprietary name (INN) or common name |
axitinib
|
Therapeutic area (MeSH) |
Carcinoma, Renal Cell
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Anatomical therapeutic chemical (ATC) code |
L01EK01
|
Publication details | |
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Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
14
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Date of issue of marketing authorisation valid throughout the European Union |
03/09/2012
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Contact address |
Pfizer Europe MA EEIG |
Product information
20/08/2021 Inlyta - EMEA/H/C/002406 - IA/0032
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Therapeutic indication
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.