Nivolumab BMS

Withdrawn

This medicine's authorisation has been withdrawn

nivolumab

Overview

The marketing authorisation for Nivolumab BMS has been withdrawn at the request of the marketing authorisation holder.

Nivolumab BMS : EPAR - Summary for the public

Nivolumab BMS : EPAR - Risk-management-plan summary

Product information

Nivolumab BMS : EPAR - Product Information

Latest procedure affecting product information: -

30/11/2015

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).

Nivolumab BMS : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Nivolumab BMS
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/003840
• Marketing authorisation holder:
  Bristol-Myers Squibb Pharma EEIG

  Plaza 254; Blanchardstown Corporate Park 2; Dublin 15; D15 T867; Ireland

• Opinion adopted:
  21/05/2015
• Marketing authorisation issued:
  20/07/2015

Assessment history

Initial marketing authorisation documents

Nivolumab BMS : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/392114/2015

CHMP summary of positive opinion for Nivolumab BMS

AdoptedReference Number: EMA/CHMP/310230/2015