Simponi: Withdrawal of the application to change the marketing authorisation
Table of contents
Overview
On 12 May 2014, Janssen Biologics B.V. officially notified the European Medicines Agency that it wished to withdraw its application to make Simponi (golimumab) also available as a concentrate (12.5 mg/ml) for solution for infusion into a vein. Simponi is available as a solution for injection under the skin at 50 and 100 mg, in pre-filled pens and syringes.Further information can be found in the assessment report under the tab 'All documents'.
Key facts
| Name |
Simponi |
| Product number |
EMEA/H/C/000992 |
| Date of issue of market authorisation valid throughout the European Union (if applicable) |
01/10/2009 |
| International non-proprietary name (INN) or common name |
|
| Active substance |
|
| Date of withdrawal |
12/05/2014 |
| Company making the application | |
| Withdrawal type |
Post-authorisation |
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').