Qalsody 100 mg solution for injection
- Licence status
- Active substances
- Tofersen
- Dosage Form
- Solution for injection
- Licence number
- EU/1/23/1783/001
- Licence holder
- Biogen Netherlands B.V.
Product documents
- Package Leaflet
- Summary of Product Characteristics
- Public Assessment Report
Licence information
- ATC code
- N07XX22 tofersen
- Legal supply status
- Product subject to prescription which may not be renewed (A)
- Place of sale
- Supply through pharmacies only
- Conditions of Licence
- Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
- Marketing availability
- Unknown
- Advertising conditions
- Advertising to healthcare professionals only
- Licence issued
- 29/05/2024