Inlyta

RSS

axitinib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 28/09/2021

Authorisation details

Product details
Name
Inlyta
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
Anatomical therapeutic chemical (ATC) code
L01EK01
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG 
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
03/09/2012
Contact address

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

20/08/2021 Inlyta - EMEA/H/C/002406 - IA/0032

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Product information documents contain:

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

Protein kinase inhibitors

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.

Assessment history

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