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 19/02/2019

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
L01XE17
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG 
Revision
9
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

22/11/2018 Inlyta - EMEA/H/C/002406 - PSUSA/00010022/201801

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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