Nivolumab BMS
nivolumab
Table of contents
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The marketing authorisation for Nivolumab BMS has been withdrawn at the request of the marketing authorisation holder.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
Authorisation details
| Product details | |
|---|---|
| Name |
Nivolumab BMS
|
| Agency product number |
EMEA/H/C/003840
|
| Active substance |
nivolumab
|
| International non-proprietary name (INN) or common name |
nivolumab
|
| Therapeutic area (MeSH) |
Carcinoma, Non-Small-Cell Lung
|
| Anatomical therapeutic chemical (ATC) code |
L01XC17
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Bristol-Myers Squibb Pharma EEIG
|
| Revision |
0
|
| Date of issue of marketing authorisation valid throughout the European Union |
20/07/2015
|
| Contact address |
Plaza 254 |
Product information
30/11/2015 Nivolumab BMS - EMEA/H/C/003840 - -
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
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Antineoplastic and immunomodulating agents
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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.