Nivolumab BMS

Withdrawn

This medicine's authorisation has been withdrawn

nivolumab

Overview

On 30 November 2015, the European Commission withdrew the marketing authorisation for Nivolumab BMS (nivolumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Bristol-Myers Squibb Pharma EEIG, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Nivolumab BMS was granted marketing authorisation in the EU on 20 July 2015 for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. The marketing authorisation was initially valid for a 5-year period. 

Nivolumab BMS is identical to Opdivo, which is also authorised in the EU to treat squamous NSCLC as well as melanoma. The marketing authorisation holder has committed to ensure that patients who need treatment with Nivolumab BMS continue to receive it until complete exhaustion of stock. Patients with squamous NSCLC currently being treated with Nivolumab BMS will then be automatically switched to Opdivo. 

The European Public Assessment Report (EPAR) for Nivolumab BMS is updated accordingly to indicate that the marketing authorisation is no longer valid.

Nivolumab BMS : EPAR - Summary for the public

Nivolumab BMS : EPAR - Risk-management-plan summary

Product information

Nivolumab BMS : EPAR - Product Information

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
• Withdrawal of marketing authorisation:
  30/11/2015

Assessment history

Initial marketing authorisation documents

Nivolumab BMS : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/392114/2015

CHMP summary of positive opinion for Nivolumab BMS

Adopted Reference Number: EMA/CHMP/310230/2015