Basic Information
Trepulmix
Regulatory Information
EMEA/H/C/005207
April 3, 2020
January 30, 2020
7
May 17, 2024
Company Information
Luxembourg
7, Fausermillen 6689 Mertert
SciPharm SARL
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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’](/en/medicines/human/orphan-designations/eu-3-13-1103) (a medicine used in rare diseases) on 8 February 2013. 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.