Aquipta 10mg and 60mg tablets
*Company:
AbbVie LimitedStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
Updated on 19 November 2024
File name
Aquipta-60mg-10mg-pl-CCDSv4_14Nov2024.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
The updated of sections 4.3, 4.4 and 4.8 of the SmPC in order to update the contraindication and warning on hypersensitivity reactions to include anaphylaxis and dyspnoea and to add them to the list of adverse drug reactions (ADRs) with frequency not known, based on a comprehensive safety review. The Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet and to introduce minor editorial changes to the PI.
Updated on 19 November 2024
File name
Aquipta-60mg-10mg-smpc-initial _CCDSv4_14Nov24.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
The updated of sections 4.3, 4.4 and 4.8 of the SmPC in order to update the contraindication and warning on hypersensitivity reactions to include anaphylaxis and dyspnoea and to add them to the list of adverse drug reactions (ADRs) with frequency not known, based on a comprehensive safety review. The Package Leaflet is updated accordingly. In addition, the MAH took the opportunity to update the list of local representatives in the Package Leaflet and to introduce minor editorial changes to the PI.
Updated on 16 October 2024
File name
Aquipta-60mg-10mg-smpc-initial _ELEVATE_10Oct24.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 5.1 - Pharmacodynamic properties, following results from the ELEVATE study.
Updated on 30 April 2024
File name
Aquipta-60mg-10mg-pl-initial MAA_11Aug23.pdf
Reasons for updating
- New PIL for new product
Updated on 30 April 2024
File name
Aquipta-60mg-10mg-smpc-initial MAA_11Aug23.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)