Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen *
Pharmacy Only: Prescription

  • Company:

    SANOFI
  • Status:

    Updated
  • Legal 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

EDM Updated on 03 February 2023

File name

63dd14d5c5659.pdf

Reasons for updating

  • Replace File

EDM Updated on 03 February 2023

File name

63dd14bda0cec.pdf

Reasons for updating

  • Replace File

EDM Updated on 03 February 2023

File name

63dd14526dd48.pdf

Reasons for updating

  • Replace File

EDM Updated on 03 February 2023

File name

63dd1401f128d.pdf

Reasons for updating

  • Replace File

EDM Updated on 03 February 2023

File name

63dd14526dd48.pdf

Reasons for updating

  • Replace File

EDM Updated on 03 February 2023

File name

63dd1401f128d.pdf

Reasons for updating

  • Replace File

EDM Updated on 13 December 2022

File name

639846053a8ef.pdf

Reasons for updating

  • Replace File

EDM Updated on 13 December 2022

File name

6398461d9fef9.pdf

Reasons for updating

  • Replace File

Updated on 18 January 2022

File name

Toujeo Doublestar - PIL Text_1642501167.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)_1597154200.pdf

Reasons for updating

  • Previous version of PIL reinstated

Updated on 10 August 2020

File name

Ireland Toujeo Solostar PIL_1597046798.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)_1596804753.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_1595256276.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)_1595248782.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)_1582803864.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)_1580913122.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_1580912955.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_1576677532.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_1576082929.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_1575891714.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)

EDM Updated on 03 September 2019

File name

2019-08-07 HPRA Approved Toujeo SoloStar DoubleStar HCP guide IE_1567497724.pdf

Reasons for updating

  • Add New Doc

EDM Updated on 03 September 2019

File name

2019-08-07 HPRA Approved Toujeo DoubleStar Patient guide IE_1567497723.pdf

Reasons for updating

  • Add New Doc

Updated on 03 September 2019

File name

1.3.1.1 SmPC Toujeo and Toujeo Doublestar_1567497508.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_1567497482.pdf

Reasons for updating

  • New PIL for new product