Febuxostat Mylan 80 mg film-coated tablets *
Pharmacy Only: Prescription

  • Company:

    Gerard Laboratories
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

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

Updated on 03 May 2022

File name

ie-pl-h4374-v014-clean_1651565861.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects

Updated on 03 May 2022

File name

ie-spc-h4374-80mg-v014-clean_1651565773.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 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 March 2022

File name

ie-spc-h4374-80mg-v013-clean_1647260566.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 18 February 2022

File name

ie-pl-h4374-renewal-clean_1645186632.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - marketing authorisation holder

Updated on 18 February 2022

File name

ie-spc-emea004374-r001-clean-80mg_1645186318.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 September 2021

File name

ie-spc-h4374-80mg-maht-clean_1632732415.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 27 September 2021

File name

ie-pl-h4374-maht-clean_1632731742.pdf

Reasons for updating

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

Updated on 10 September 2020

File name

ie-PIL-h4374-clean-IA009_1599731826.pdf

Reasons for updating

  • Improved presentation of PIL

Updated on 03 January 2020

File name

ie-PIL-h4374-clean-IB008_1578057546.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 03 January 2020

File name

ie-SPC-h4374-clean-IB008_1578057458.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 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 30 April 2019

File name

Febuxostat Package leaflet_1556610022.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 April 2019

File name

Febuxostat SPC 80mg_1556610050.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)