Janacti: Withdrawal of the marketing authorisation application

sitagliptin/pioglitazone

Overview

On 7 November 2011 Merck Sharp & Dohme Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Janacti and related names, for the treatment of type 2 diabetes.

Key facts

Name
Janacti
Product number
EMEA/H/C/002394
International non-proprietary name (INN) or common name
  • sitagliptin/pioglitazone
Active substance
  • sitagliptin/pioglitazone
Date of withdrawal
07/11/2011
Company making the application
Merck Sharp Dohme Ltd.
Withdrawal type
Initial authorisation

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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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