AUBAGIO 7mg mg film-coated tablets
*Company:
Sanofi GenzymeStatus:
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 01 April 2025
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE (3).pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 10 March 2025
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 November 2024
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 7mg (3) (1).pdf
Reasons for updating
- Improved presentation of PIL
File name
Patient Card - Aubagio IE (2).pdf
Reasons for updating
- Replace File
Updated on 01 October 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (6).pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 September 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (5).pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 August 2024
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 7mg (3).pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 01 August 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (4).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
HCP Guide - Aubagio IE.pdf
Reasons for updating
- Replace File
File name
Patient Card - Aubagio IE.pdf
Reasons for updating
- Replace File
Updated on 07 May 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI (3).pdf
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 May 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio IE & NI.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may not be renewed (A)
File name
AUB-2021-061_HCP_Discussion_Guide_IE_V7.pdf
Reasons for updating
- Add New Doc
File name
AUB-2021-060_Aubagio_Patient_Card_IE_MAT-IE-2101438 v2.0 (1).pdf
Reasons for updating
- Add New Doc
Updated on 19 June 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Aubagio.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 June 2023
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Aubagio 7mg.pdf
Reasons for updating
- New PIL for new product
Sanofi Genzyme
Address:
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELANDMedical Information E-mail:
iemedinfo@sanofi.comTelephone:
+353 1 4035600