Nivolumab BMS

nivolumab

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The marketing authorisation for Nivolumab BMS has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Nivolumab BMS : EPAR - Summary for the public BG = bălgarski 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public ES = español 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public CS = čeština 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public DA = dansk 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public DE = Deutsch 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public ET = eesti keel 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public EL = elliniká 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public FR = français 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public IT = italiano 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public LV = latviešu valoda 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public LT = lietuvių kalba 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public HU = magyar 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public MT = Malti 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public NL = Nederlands 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public PL = polski 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public PT = português 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public RO = română 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public SK = slovenčina 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public SL = slovenščina 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public FI = suomi 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public SV = svenska 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Summary for the public HR = Hrvatski 27/07/2015 14/01/2016
Name Language First published Last updated
Nivolumab BMS : EPAR - Risk-management-plan summary (English only) 27/07/2015 14/01/2016

This EPAR was last updated on 14/01/2016 .

Authorisation details

Product details

Product details for Nivolumab BMS
NameNivolumab BMS
Agency product numberEMEA/H/C/003840
Active substance

nivolumab

International non-proprietary name (INN) or common name

nivolumab

Therapeutic area Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code L01XC17

Publication details

Publication details for Nivolumab BMS
Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

Revision0
Date of issue of marketing authorisation valid throughout the European Union20/07/2015

Contact address:

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park 
Sanderson Road 
Uxbridge UB8 1DH 
United Kingdom

Product information

Product information

30/11/2015  Nivolumab BMS -EMEA/H/C/003840 --

Name Language First published Last updated
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - Product Information EN = English 27/07/2015 14/01/2016

Contents

  • 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

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.


Name Language First published Last updated
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016
Nivolumab BMS : EPAR - All Authorised presentations EN = English 27/07/2015 14/01/2016

Pharmacotherapeutic group

Antineoplastic and immunomodulating agents, monoclonal antibodies

Therapeutic indication

Nivolumab BMS is indicated for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Nivolumab BMS : EPAR - Public assessment report EN = English 27/07/2015 14/01/2016
CHMP summary of positive opinion for Nivolumab BMS EN = English 22/05/2015 14/01/2016

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Nivolumab BMS