Orepaxam (treprostinil diolamine)
- Region
- 🇪🇺 EU
- Active substance
- treprostinil diolamine
- Company
- Ferrer Internacional S.A.
- Status
- Application withdrawn
- Therapeutic area
- Hypertension, Pulmonary
- Designations
- Orphan
- Application
- EMEA/H/C/005990
- ATC
- B01AC21
- Official record
- www.ema.europa.eu
Indication
Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression and to improve exercise capacity. The studies that established effectiveness included predominantly patients with WHO functional class II-III symptoms and aetiologies of idiopathic or heritable PAH or PAH associated with connective tissue disease (see section 5.1). Treatment of pulmonary arterial hypertension (PAH) (WHO Group 1).
Regulatory milestones
No milestones recorded in the last year.
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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.