Suvezen 20 mg/10 mg film-coated tablets *
Pharmacy Only: Prescription

  • 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 09 December 2022

File name

6393235d87c3d.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

63932326b7096.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

63888dc39cd66.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

62c403aaec85b.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

62c40375d687f.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_1643810667.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 20mg-10mg Clean_1643810578.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)_1631788138.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 27 May 2020

File name

1.3.2.1 Ireland Suvezen PIL (1)_1590583815.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 20mg10mg_1576245644.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_1576245611.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 29 July 2019

File name

ie-suvezen leaflet text IE966_1564398148.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 July 2019

File name

1.3.1 SPC Suvezen 20mg10mg PA540193002 IE560 National text_1564413563.pdf

Reasons for updating

  • New SPC for new product

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