Febuxostat Mylan 120 mg film-coated tablets *
Company:
Gerard LaboratoriesStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)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-h4374-120mg-maht-clean_1632732508.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 not be renewed (A)
Updated on 27 September 2021
File name
ie-pl-h4374-maht-clean_1632732461.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_1599731859.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 03 January 2020
File name
ie-SPC-h4374-clean-IB008_1578063285.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 not be renewed (A)
Updated on 03 January 2020
File name
ie-PIL-h4374-clean-IB008_1578063167.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 30 April 2019
File name
Febuxostat Package leaflet_1556610435.pdf
Reasons for updating
- New PIL for new product
Updated on 30 April 2019
File name
Febuxostat SPC 120_1556610464.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)