SmPC - Digoxin Tablets BP 62.5 micrograms: Change history
View Summary of Product Characteristics (SmPC - Digoxin Tablets BP 62.5 micrograms)
Last updated on this site: 17 Aug 2023
To register section 3.2.P.7 Container Closure System for the 20μ Aluminium/250μ PVC blister packaging. There are also updates to section 6.5 of the SmPC (removal of reference to the heat seal lacquer). The label and leaflet are unaffected by this variation.
Last updated on this site: 17 Aug 2023
To register section 3.2.P.7 Container Closure System for the 20μ Aluminium/250μ PVC blister packaging. There are also updates to section 6.5 of the SmPC (removal of reference to the heat seal lacquer). The label and leaflet are unaffected by this variation.
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Changes: (Updated: 17 Aug 2023)
To register section 3.2.P.7 Container Closure System for the 20μ Aluminium/250μ PVC blister packaging. There are also updates to section 6.5 of the SmPC (removal of reference to the heat seal lacquer). The label and leaflet are unaffected by this variation.
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Changes: (Updated: 04 Jan 2023)
Variation Description: To reduce the finished product shelf life from 3 years to 2 years for product packed in PVC/Aluminium blister packs due to a stability study failure for tablet dissolution at 36 months. Section 6.3 of the SmPC is updated accordingly.
SmPC section(s) updated– 6.3, 10.
No changes to artwork.
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Changes: (Updated: 20 Sep 2022)
Initial upload