Trepulmix (treprostinil)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- treprostinil
- Company
- SciPharm Sàrl
- Status
- Authorised
- Therapeutic area
- Hypertension, Pulmonary
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Fri 03 Apr 2020
- Designations
- Orphan
- Application
- EMEA/H/C/005207
- ATC
- B01AC21
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Orepaxam Application withdrawn · Ferrer Internacional S.A.
- 🇪🇺 Treprostinil SciPharm Sàrl Application withdrawn · SciPharm Sàrl
- 🇪🇺 Tyvaso Application withdrawn · United Therapeutics Europe Ltd
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.