Suvezen 40 mg/10 mg film-coated tablets

  • Company:

    SANOFI
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • *Additional information is available within the SPC or upon request to the company

Updated on 14 November 2023

File name

1.3.1.1 Suvezen 40mg-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 40mg-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 40mg-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 40mg-10mg (3).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

  • Improved presentation of PIL

Updated on 09 December 2022

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Suvezen 40mg-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 09 December 2022

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Suvezen 40mg-10mg - clean (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 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains

Updated on 01 December 2022

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Suvezen 40mg-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 40mg-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 Suvezen Ireland 40mg-10mg SmPC - 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 16 September 2021

File name

1.3.2.1 Ireland Suvezen PIL (2).pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 27 May 2020

File name

1.3.2.1 Ireland Suvezen PIL (2).pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 December 2019

File name

Suvezen 40mg-10mg SmPC.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

File name

ie-suvezen leaflet text IE966.pdf

Updated on 29 July 2019

File name

1.3.1 SPC Suvezen 40mg10mg PA540193003 IE560 National text.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 29 July 2019

File name

ie-suvezen leaflet text IE966.pdf

Reasons for updating

  • New PIL for new product