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 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_Patient Alert Card_June 2021.pdf
Reasons for updating
- Replace File
File name
TYSABRI_Discontinuation_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_Initiation_Form_June 2021.pdf
Reasons for updating
- Replace File
File name
TYSABRI_Physician Information Document_June 2021.pdf
Reasons for updating
- Replace File
File name
Tysabri Patient Alert Card_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 Continuation form_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_Physician Information Document_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)