Suvezen 10 mg/10 mg film-coated tablets
*Company:
SANOFIStatus:
No Recent UpdateLegal 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 27 September 2024
File name
1.3.2.1 Suvezen PL Text IE (3).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 27 September 2024
File name
1.3.1.1 Suvezen 10mg-10mg SmPC IE (2).pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 September 2024
File name
1.3.1.1 Suvezen 10mg-10mg SmPC IE (2).pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Updated on 16 July 2024
File name
1.3.2.1 Suvezen PL Text IE (2).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 27 June 2024
File name
1.3.1.1 Suvezen 10mg-10mg SmPC IE.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2024
File name
875349 PIL (1).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
Updated on 14 November 2023
File name
1.3.1.1 Suvezen 10mg-10mg SmPC IE (2).pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 September 2023
File name
1.3.1.1 Suvezen 10mg-10mg SmPC IE (1).pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 May 2023
File name
1.3.2.1 Suvezen PL Text IE.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
Updated on 17 May 2023
File name
1.3.1.1 Suvezen 10mg-10mg SmPC IE.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 03 February 2023
File name
1.3.2.1 Package Leaflet (PIL text) Suvezen.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 02 February 2023
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Suvezen 10mg-10mg (1).pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 February 2023
File name
1.3.2.1 PIL Mock-up IE & UK-NI.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
Updated on 09 December 2022
File name
1.3.2.1 Package Leaflet (PIL text) Suvezen - clean.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 - 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
- Change to section 6 - what the product contains
Updated on 09 December 2022
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Suvezen 10mg-10mg - clean (1).pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 01 December 2022
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Suvezen 10mg-10mg - clean.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 July 2022
File name
1.3.2.1 Package Leaflet (PIL text) Suvezen.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
Updated on 05 July 2022
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Suvezen 10mg-10mg.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 February 2022
File name
1.3.2.1 Ireland Suvezen PIL Text.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 02 February 2022
File name
1.3.1.1 Ireland Suvezen SmPC 10mg-10mg Clean.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 27 May 2020
File name
1.3.2.1 Ireland Suvezen PIL.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 December 2019
File name
Suvezen SmPC 10mg10mg.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 13 December 2019
File name
Suvezen PIL.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 29 July 2019
File name
ie-suvezen leaflet text IE966.pdf
Reasons for updating
- New PIL for new product
Updated on 29 July 2019
File name
1.3.1 SPC Suvezen 10mg10mg PA540193001 IE560.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
SANOFI
Address:
Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
iemedinfo@sanofi.comTelephone:
+353 1 4035600