Sileo - withdrawal of application for variation to marketing authorisation

Application withdrawn

The application for a change to this medicine's authorisation has been withdrawn

dexmedetomidine

Overview

In accordance with Article 16 of Commission Regulation (EC) No 1234/2008, the marketing authorisation holder, Orion Corporation (the applicant), submitted to the European Medicines Agency (the Agency) on 22 December 2021 an application for a type II variation for Sileo.

On 30 August 2022, the applicant withdrew the application. In its letter notifying the Agency of the withdrawal of application, the applicant states that “the reason for withdrawal is based on a commercial decision.”

Key facts

• Name of medicine:
  Sileo
• EMA product number:
  EMEA/V/C/003764
• Active substance:
  Dexmedetomidine hydrochloride
• International non-proprietary name (INN) or common name:
  dexmedetomidine
• Date of withdrawal:
  30/08/2022

Documents

Withdrawal assessment report for Sileo (II-22)

Adopted Reference Number: EMA/767835/2022

Withdrawal letter: Sileo (II-22)