Zynlonta 10 mg powder for concentrate for solution for infusion
*Company:
Swedish Orphan Biovitrum LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)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 20 November 2024
File name
Zynlonta SPC IE NI (November 2024).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 November 2024
File name
Zynlonta PIL IE NI (November 2024).pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 16 February 2024
File name
Zynlonta SPC IE NI (February 2024).pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Removal in Annex II.E. of study LOTIS-2 (ADCT-402-201) as specific obligation, since completed
File name
Sobi Zynlonta RMM_Patient Card ROI NP-28942.pdf
Reasons for updating
- Add New Doc
File name
Sobi Zynlonta RMM_Patient Card ROI NP-28942.pdf
Reasons for updating
- Add New Doc
Updated on 02 June 2023
File name
Zynlonta PIL IE NI (May 2023).pdf
Reasons for updating
- Change to MA holder contact details
Updated on 15 May 2023
File name
Zynlonta SPC IE NI (May 2023).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 May 2023
File name
Zynlonta PIL IE NI (May 2023).pdf
Reasons for updating
- New PIL for new product