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
- Ramelteon
- Therapeutic area
- Sleep Initiation and Maintenance Disorders
- Marketing authorisation holder
- Takeda Global Research Development Centre (Europe) Ltd.
- Status
- Application withdrawn
- EMA product number
- EMEA/H/C/000838
EMA designations
- Orphan medicine
- No
- Conditional approval
- No
- Biosimilar
- No
- Generic
- No
- Accelerated assessment
- No
- Additional monitoring
- No
- Patient safety information
- No