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 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