Treprostinil SciPharm Sàrl : Withdrawal of the marketing authorisation application

treprostinil

Overview

On 5 September 2018, SciPharm Sàrl officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Treprostinil SciPharm Sàrl, for the treatment of chronic thromboembolic pulmonary hypertension (high blood pressure in the lungs because of blocked blood vessels).

Key facts

Name
Treprostinil SciPharm Sàrl
Product number
EMEA/H/C/004847
International non-proprietary name (INN) or common name
  • treprostinil
Active substance
  • Treprostinil
Date of withdrawal
05/09/2018
Company making the application
SciPharm Sàrl
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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