Natalizumab Elan Pharma

Refused

This medicine has been refused authorisation

natalizumab

Overview

On 19 July 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Natalizumab Elan Pharma concentrate for solution for infusion, intended for the treatment of Crohn’s disease. The company that applied for authorisation is Elan Pharma International Ltd. The applicant requested a re-examination of the opinion. After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed their recommendation for the refusal of the marketing authorisation on 15 November 2007.

Questions and answers on the recommendation for the refusal of the marketing authorization for Natalizumab Elan Pharma

Product details

• Name of medicine:
  Natalizumab Elan Pharma
• Active substance:
  natalizumab
• International non-proprietary name (INN) or common name:
  natalizumab
• Therapeutic area (MeSH):
  Crohn Disease
• Anatomical therapeutic chemical (ATC) code:
  L03AD

Pharmacotherapeutic group

Immunostimulants

Application details

• EMA product number:
  EMEA/H/C/000624
• Marketing authorisation applicant:
  Elan Pharma International Ltd.
• Opinion adopted:
  15/11/2007
• Refusal of marketing authorisation:
  11/01/2008

Assessment history

Natalizumab Elan Pharma : EPAR - Refusal public assessment report