Composition
- Active substance
- sinapultide, Dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol, palmitic acid
- International name (INN)
- sinapultide;dipalmitoylphosphatidylcholine;palmitoyl-oleoyl phosphatidylglycerol;palmitic acid
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
- Surfaxin
- Therapeutic area
- Respiratory Distress Syndrome, Newborn
- Marketing authorisation holder
- Pharm Research Associates (UK) Limited
- Status
- Application withdrawn
- EMA product number
- EMEA/H/C/000625
EMA designations
- Orphan medicine
- Yes
- Conditional approval
- No
- Biosimilar
- No
- Generic
- No
- Accelerated assessment
- No
- Additional monitoring
- No
- Patient safety information
- No