Qalsody 100mg solution for injection
*Company:
Biogen Idec (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to restricted prescription (C)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 05 May 2026
File name
IE SmPC 101-102 update.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
Update to sections 4.8, 5.1 and 5.2 after inclusion of final integrated safety data from studies 233AS101 and 233AS102.
Updated on 24 March 2026
File name
IE SmPC final.pdf
Reasons for updating
- Error on previous SPC conversion
Legal category:Product subject to restricted prescription (C)
Updated on 19 December 2025
File name
IE SmPC final.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to restricted prescription (C)
Free text change information supplied by the pharmaceutical company
New SmPC for new product
Updated on 19 December 2025
File name
IE PIL.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
New PIL for new product
Biogen Idec (Ireland) Ltd
Address:
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, IrelandMedical Information E-mail:
MedInfoUKI@biogen.comMedical Information Direct Line:
1800 812 719