Febuxostat Mylan 80 mg film-coated tablets *

  • Company:

    Gerard Laboratories
  • Status:

    Updated
  • 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

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

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)