Toujeo 300 units/ml DoubleStar, solution for injection in a pre-filled pen * Pharmacy Only: Prescription
Company:
SANOFIStatus:
UpdatedLegal 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
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63dd14d5c5659.pdf
Reasons for updating
- Replace File
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63dd14bda0cec.pdf
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63dd14526dd48.pdf
Reasons for updating
- Replace File
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63dd1401f128d.pdf
Reasons for updating
- Replace File
File name
63dd14526dd48.pdf
Reasons for updating
- Replace File
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63dd1401f128d.pdf
Reasons for updating
- Replace File
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639846053a8ef.pdf
Reasons for updating
- Replace File
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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)
File name
2019-08-07 HPRA Approved Toujeo SoloStar DoubleStar HCP guide IE_1567497724.pdf
Reasons for updating
- Add New Doc
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