Tysabri 150 mg solution for injection in pre-filled syringe
*Company:
Biogen Idec (Ireland) LtdStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 06 May 2025
File name
250422A ie-150 mg-PIL_TOR CDSv36_clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change to section 7 - Instructions for use
Free text change information supplied by the pharmaceutical company
Amendment of ambient storage temperature and instructions allowing for return to refrigerator, for up to 24 hours.
Updated on 06 May 2025
File name
250422A ie-150 mg-SmPC_TOR CDSv36_clean.pdf
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Amendment of ambient storage temperature and instructions allowing for return to refrigerator, for up to 24 hours.
Updated on 30 October 2024
File name
IE NI 150mg PIL CDS v35.pdf
Reasons for updating
- Change to other sources of information section
Updated on 30 October 2024
File name
IE-NI 150mg SmPC CDSv 35.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 10 June 2024
File name
IE-NI Tysabri 150 mg SmPC_SLE and ATC code change cl.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
File name
Tysabri PID OCS administration checklist.pdf
Reasons for updating
- Replace File
File name
Tysabri PID OCS administration checklist.pdf
Reasons for updating
- Add New Doc
File name
Tysabri PID HCP information supplement.pdf
Reasons for updating
- Add New Doc
File name
Tysabri Physician Information Document (PID) v22.pdf
Reasons for updating
- Replace File
Updated on 06 March 2024
File name
IE-NI updated Leaflet Tysabri SC outside a clinical setting.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to information for healthcare professionals
- Change to date of revision
Updated on 06 March 2024
File name
IE-NI updated SmPC Tysabri SC outside a clinical setting.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 June 2022
File name
SmPC-150mg pdf.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 April 2022
File name
Tysabri 150mg SmPC IE-NI.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 medical prescription which may be renewed (B)
Updated on 06 April 2022
File name
m1-3-1-SPC-clean-150mg-NOVA.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 medical prescription which may be renewed (B)
Updated on 02 September 2021
File name
Tysabri 150 mg solution for injection in pre-filled syringe _PIL_Aug 2021.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to date of revision
Updated on 02 September 2021
File name
Tysabri 150 mg solution for injection in pre-filled syringe_SmPC_Aug 2021.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
File name
TYSABRI_Physician Information Document_June 2021.pdf
Reasons for updating
- Replace File
File name
TYSABRI_Initiation_Form_June 2021.pdf
Reasons for updating
- Replace File
File name
TYSABRI_Continuation_Form_June 2021.pdf
Reasons for updating
- Replace File
File name
TYSABRI_Discontinuation_Form_June 2021.pdf
Reasons for updating
- Replace File
File name
TYSABRI_Patient Alert Card_June 2021.pdf
Reasons for updating
- Replace File
File name
Tysabri_Physician Information Document_2021.pdf
Reasons for updating
- Add New Doc
File name
Tysabri Patient Initiation form_2021.pdf
Reasons for updating
- Add New Doc
File name
Tysabri Patient Continuation form_2021.pdf
Reasons for updating
- Add New Doc
File name
Tysabri Patient Discontinuation form_2021.pdf
Reasons for updating
- Add New Doc
File name
Tysabri Patient Alert Card_2021.pdf
Reasons for updating
- Add New Doc
Updated on 15 April 2021
File name
Tysabri 150 mg mg solution for injection in pre-filled syringe PIL.pdf
Reasons for updating
- New PIL for new product
Updated on 15 April 2021
File name
Tysabri 150 mg solution for injection in pre-filled syringe.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
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