Febuxostat Mylan 80 mg film-coated tablets * Pharmacy Only: Prescription
Company:
Gerard LaboratoriesStatus:
No Recent UpdateLegal 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)