Tyvaso:

Withdrawal of the marketing authorisation application

treprostinil sodium

Overview

On 17 February 2010, United Therapeutics Europe Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Tyvaso, intended to be used as an 'add on' treatment for patients with pulmonary arterial hypertension.

Key facts

Name
Tyvaso
Product number
EMEA/H/C/001115
International non-proprietary name (INN) or common name
  • treprostinil sodium
Active substance
  • Treprostinil sodium
Date of withdrawal
17/02/2010
Company making the application
United Therapeutics Europe Ltd
Withdrawal type
Initial authorisation

Related content

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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