Ibuprofen/Diphenhydramine Hydrochloride Wyeth: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 7 January 2010, Wyeth Consumer Healthcare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth, for use in the treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain.
Key facts
Name |
Ibuprofen/Diphenhydramine Hydrochloride Wyeth |
Product number |
EMEA/H/C/001108 |
Active substance |
|
Date of withdrawal |
07/01/2010 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Ibuprofen/Diphenhydramine Hydrochloride Wyeth (PDF/1.06 MB)
Adopted
First published: 20/04/2010
Last updated: 20/04/2010
EMA/CHMP/239978/2010 -
List item
Withdrawal letter: Ibuprofen/Diphenhydramine Hydrochloride Wyeth (PDF/25.42 KB)
First published: 28/01/2010
Last updated: 28/01/2010 -
List item
Wyeth Consumer Healthcare withdraws its marketing authorisation application for Ibuprofen/Diphenhydramine Hydrochloride Wyeth (PDF/57.38 KB)
First published: 13/01/2010
Last updated: 13/01/2010
EMA/23476/2010 -
List item
Questions and answers on the withdrawal of the marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth (PDF/65.62 KB)
First published: 28/01/2010
Last updated: 28/01/2010
EMA/23377/2010 -
Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').