Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen
*Company:
SANOFIStatus:
No Recent UpdateLegal 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 11 November 2024
File name
Toujeo Doublestar - PIL Text.pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 11 November 2024
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Toujeo DoubleStar (5).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 11 November 2024
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Toujeo DoubleStar (5).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 15 December 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Toujeo - IE & UK(NI).pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 October 2023
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Toujeo DoubleStar (1).pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
File name
Toujeo RMM HCP guide IE MAT-IE-2200530 (V2.0).pdf
Reasons for updating
- Replace File
File name
Toujeo RMM Patient guide IE MAT-IE-2200529 (v2.0).pdf
Reasons for updating
- Replace File
File name
HCP Guide Home Infusion - United Kingdom.pdf
Reasons for updating
- Replace File
File name
Toujeo RMM Patient guide IE MAT-IE-2200529 (v2.0).pdf
Reasons for updating
- Replace File
File name
HCP Guide Home Infusion - United Kingdom.pdf
Reasons for updating
- Replace File
File name
Toujeo RMM Patient guide IE MAT-IE-2200529 (v2.0).pdf
Reasons for updating
- Replace File
File name
Toujeo RMM HCP guide IE.pdf Approved for distribution.pdf
Reasons for updating
- Replace File
File name
Toujeo RMM Patient guide IE.pdf Approved for distribution.pdf
Reasons for updating
- Replace File
Updated on 18 January 2022
File name
Toujeo Doublestar - PIL Text.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 11 August 2020
File name
Ireland Toujeo DoubleStar PIL (3).pdf
Reasons for updating
- Previous version of PIL reinstated
Updated on 10 August 2020
File name
Ireland Toujeo Solostar PIL.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 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Updated on 07 August 2020
File name
Ireland Toujeo DoubleStar PIL (2).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 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 20 July 2020
File name
Ireland Toujeo and Toujeo Doublestar SmPC.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 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 20 July 2020
File name
Ireland Toujeo and Toujeo Doublestar SmPC (1).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 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 be renewed (B)
Updated on 27 February 2020
File name
1.3.2.1 Toujeo DoubleStar PIL (2).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 05 February 2020
File name
1.3.1.1 SmPC Toujeo and Toujeo Doublestar (2).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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Label update requested by the PRAC during the insulin glargine PSUSA
Updated on 05 February 2020
File name
1.3.2.1 Toujeo DoubleStar PIL.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 18 December 2019
File name
Toujeo DoubleStar PIL.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
Updated on 11 December 2019
File name
Toujeo and Toujeo Doublestar SmPC.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 09 December 2019
File name
Toujeo SmPC.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- 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)
File name
2019-08-07 HPRA Approved Toujeo SoloStar DoubleStar HCP guide IE.pdf
Reasons for updating
- Add New Doc
File name
2019-08-07 HPRA Approved Toujeo DoubleStar Patient guide IE.pdf
Reasons for updating
- Add New Doc
Updated on 03 September 2019
File name
1.3.1.1 SmPC Toujeo and Toujeo Doublestar.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 September 2019
File name
1.3.2.1 Toujeo DoubleStar PIL.pdf
Reasons for updating
- New PIL for new product