Nivolumab BMS
nivolumab
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Nivolumab BMS has been withdrawn at the request of the marketing authorisation holder.
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List item
Nivolumab BMS : EPAR - Summary for the public (PDF/545.33 KB)
First published: 27/07/2015
Last updated: 14/01/2016 -
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List item
Nivolumab BMS : EPAR - Risk-management-plan summary (PDF/575.85 KB)
First published: 27/07/2015
Last updated: 14/01/2016
This EPAR was last updated on 14/01/2016
Authorisation details
| Product details | |
|---|---|
| Name |
Nivolumab BMS
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| Agency product number |
EMEA/H/C/003840
|
| Active substance |
nivolumab
|
| International non-proprietary name (INN) or common name |
nivolumab
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| Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
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| Anatomical therapeutic chemical (ATC) code |
L01XC17
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| Publication details | |
|---|---|
| Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
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| Revision |
0
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| Date of issue of marketing authorisation valid throughout the European Union |
20/07/2015
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| Contact address | |
Product information
30/11/2015 Nivolumab BMS - EMEA/H/C/003840 - -
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.
Pharmacotherapeutic group
Pharmacotherapeutic group
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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
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Monoclonal antibodies
Therapeutic indication
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.