SmPC - Prednisolone 5mg Gastro-resistant Tablets: Change history
View Summary of Product Characteristics (SmPC - Prednisolone 5mg Gastro-resistant Tablets)
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: 24 Jan 2023)
Variation Description: To update sections 4.1, 4.2 and 4.4 of the SmPC and PIL in line with reference product (Deltacortril 1mg Gastro-resistant Tablets, MAH: Phoenix Labs, SmPC updated: 21/07/2020).
SmPC sections updated – 4.1, 4.2, 4.4 and 10
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Changes: (Updated: 21 Sep 2022)
Initial upload