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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Natalizumab Elan Pharma : EPAR - Refusal public assessment report (PDF/407.2 KB)
First published: 25/01/2008
Last updated: 25/01/2008 -
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Questions and answers on the recommendation for the refusal of the marketing authorization for Natalizumab Elan Pharma (PDF/78.52 KB)
First published: 25/01/2008
Last updated: 25/01/2008 -