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Renvela 0.8 g powder for oral suspension

*
Pharmacy Only: Prescription

  • Company:

    SANOFI

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Sevelamer Hydrochloride

    *Additional information is available within the SPC or upon request to the company

Updated on 05 October 2023

File name

1.3.2.1 Mock-up PIL IENI 0.8g ROVI (1).pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 05 October 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Renvela 0.8g Sachet (UK(NI), IE) (1).pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 7 - Marketing authorisation holder

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

Updated on 05 October 2023

File name

1.3.2.1 Mock-up PIL IENI 0.8g ROVI (1).pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 03 October 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Renvela 0.8g Sachet (UK(NI), IE).pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Updated on 03 October 2023

File name

1.3.2.1 Mock-up PIL IENI 0.8g ROVI.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer

Updated on 08 June 2023

File name

1.3.1.1 Summary of Product Characteristics (SmPC) Renvela 0.8g Sachet (UK(NI), IE) (1).pdf

Reasons for updating

  • Improved presentation of SPC

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

Updated on 08 June 2023

File name

1.3.2.1 Mock-up PIL IENI 0.8g ROVI (1).pdf

Reasons for updating

  • 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
  • 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

Updated on 26 January 2022

File name

1.3.1 Renvela 0.8g Sachet - SPC -IENI.pdf

Reasons for updating

  • Improved presentation of SPC

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

Updated on 25 January 2022

File name

1.3.1.1 SmPC Renvela 0.8g.pdf

Reasons for updating

  • Improved presentation of SPC

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

Updated on 24 January 2022

File name

IE PIL Text 0.8g.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 05 November 2021

File name

1.3.1.2 PIL Text 0.8g .pdf

Reasons for updating

  • New PIL for new product

Updated on 05 November 2021

File name

1.3.1.1 SmPC Renvela 0.8g.pdf

Reasons for updating

  • New SPC for new product

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