Trepulmix

RSS

treprostinil

Authorised
This medicine is authorised for use in the European Union.

Overview

Trepulmix is a medicine for use in the treatment of chronic thromboembolic pulmonary hypertension (CTEPH), a condition linked with high blood pressure in the lungs caused by blood clots. It can be used to improve the capacity for physical activity in patients:

  • who cannot have an operation for treating the condition;
  • whose condition remains or continues to return after an operation to treat it.

CTEPH is rare, and Trepulmix was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 February 2013. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3131103.

Trepulmix is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but it is used for treating a different form of pulmonary hypertension. The reference medicine for Trepulmix is Remodulin.

Trepulmix contains the active substance treprostinil.

This EPAR was last updated on 08/04/2020

Authorisation details

Product details
Name
Trepulmix
Agency product number
EMEA/H/C/005207
Active substance
Treprostinil sodium
International non-proprietary name (INN) or common name
treprostinil
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
B01AC21
OrphanOrphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
SciPharm Sàrl
Date of issue of marketing authorisation valid throughout the European Union
03/04/2020
Contact address

7, Fausermillen
6689 Mertert
Luxembourg

Product information

Trepulmix - EMEA/H/C/005207 -

Contents

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Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Treatment of adult patients with WHO Functional Class (FC) III or IV and:

- inoperable chronic thromboembolic pulmonary hypertension (CTEPH), or

- persistent or recurrent CTEPH after surgical treatment

to improve exercise capacity.

Assessment history

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