AUBAGIO 7mg mg film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Sanofi Genzyme
  • Status:

    Updated
  • Legal 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

EDM Updated on 02 October 2024

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)

EDM Updated on 23 July 2024

File name

HCP Guide - Aubagio IE.pdf

Reasons for updating

  • Replace File

EDM Updated on 23 July 2024

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)

EDM Updated on 19 June 2023

File name

AUB-2021-061_HCP_Discussion_Guide_IE_V7.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 19 June 2023

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