Natalizumab Elan Pharma

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natalizumab

Refused
This medicine was refused authorisation for use in the European Union.

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.

This EPAR was last updated on 25/01/2008

Application details

Product details
Name
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
Application details
Marketing-authorisation applicant
Elan Pharma International Ltd.
Date of opinion
15/11/2007
Date of refusal of marketing authorisation
11/01/2008

Assessment history

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