Fingolimod 0.5 mg hard capsules
*Company:
Flynn Pharma LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 29 April 2025
File name
2025-04-28_ie-pl-0i5mg-cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 29 April 2025
File name
2025-04-28_ie-spc-0i5mg-cl.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The following sections of the SmPC were impacted: Section 4.3 - PML added to contraindications; Section 4.4 - PML and IRIS added to warnings; Section 4.8 - IRIS added to undesirable effects; Section 6.4 – Editorial update made to storage conditions.
File name
Fingolimod IE prescribers checklist_clean v2.pdf
Reasons for updating
- Replace File
Updated on 14 January 2025
File name
2024-11-28_ie-spc-0i5mg_clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 January 2025
File name
2024-10-02_ie-pl-fingolimod-0i5mg clean.pdf
Reasons for updating
- New PIL for new product
File name
Fingolimod IE prescribers checklist_clean (1).pdf
Reasons for updating
- New EDM File
File name
Fingolimod IE Flynn patient, parent, caregiver guide_clean.pdf
Reasons for updating
- New EDM File
File name
Fingolimod IE Flynn pregnancy specific patient reminder card_clean.pdf
Reasons for updating
- New EDM File
Flynn Pharma Ltd
Address:
5th Floor, 40 Mespil Road, Dublin 4, IRELAND, D04 C2N4Medical Information E-mail:
medinfo@flynnpharma.comMedical Information Direct Line:
+44 (0)1438 727822