Composition
- Active substance
- rubitecan
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
- Orathecin
- Active substance
- rubitecan
- Therapeutic area
- Pancreatic Neoplasms
- Marketing authorisation holder
- EuroGen Pharmaceuticals Ltd
- Status
- Application withdrawn
- EMA product number
- EMEA/H/C/000608
EMA designations
- Orphan medicine
- Yes
- Conditional approval
- No
- Biosimilar
- No
- Generic
- No
- Accelerated assessment
- No
- Additional monitoring
- No
- Patient safety information
- No