Composition
- Active substance
- treprostinil sodium
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Medicine
- Tyvaso
- Active substance
- treprostinil sodium
- Therapeutic area
- Hypertension, Pulmonary
- Marketing authorisation holder
- United Therapeutics Europe Ltd
- Status
- Application withdrawn
- EMA product number
- EMEA/H/C/001115
EMA designations
- Orphan medicine
- Yes
- Conditional approval
- No
- Biosimilar
- No
- Generic
- No
- Accelerated assessment
- No
- Additional monitoring
- No
- Patient safety information
- No