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Evrenzo Film-Coated Tablets

*
Pharmacy Only: Prescription

  • Company:

    Astellas Pharma Co. Ltd

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Roxadustat

    This medicinal product is subject to additional monitoring.

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

Updated on 04 April 2024

File name

NI-IE-pil-clean-Apr2024.pdf

Reasons for updating

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

Updated on 06 June 2023

File name

NI-IE Evrenzo SmPC 02-06-2023.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 06 June 2023

File name

NI-IE Evrenzo PIL 02-06-2023.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 06 October 2022

File name

NI-IE Evrenzo SmPC 30-09-2022.pdf

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 28 September 2022

File name

NI-IE Evrenzo PIL 27-09-2022.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 28 September 2022

File name

NI-IE Evrenzo SmPC 27-09-2022.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 10 - Date of revision of the text

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

Updated on 21 July 2022

File name

IE-NI Evrenzo SmPC 18-07-2022_cl.pdf

Reasons for updating

  • 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 not be renewed (A)

Updated on 21 July 2022

File name

IE-NI Evrenzo PIL 07-2022_cl.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 16 May 2022

File name

Evrenzo film-coated tablets IE 08-2021.pdf

Reasons for updating

  • New SPC for new product

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

Updated on 16 May 2022

File name

Evrenzo-tablets-PIL-IE Aug-2021.pdf

Reasons for updating

  • New PIL for new product