SmPC - Flecainide Acetate Tablets 50mg: Change history
View Summary of Product Characteristics (SmPC - Flecainide Acetate Tablets 50mg)
Last updated on this site: 07 Aug 2024
To update sections 4.3, 4.4, 4.5, 4.6, 4.9, 5.1, 5.2 and 5.3 of
the SmPC in line with the reference product Tambocor 50 mg
Tablets (MA number: PA2010/026/002; MAH: Mylan IRE
Healthcare Limited; dated September 2020). Consequentially,
the PIL has been updated.
Additional minor formatting updates to SmPC section 4.5 and
the PIL.
Last updated on this site: 07 Aug 2024
To update sections 4.3, 4.4, 4.5, 4.6, 4.9, 5.1, 5.2 and 5.3 of
the SmPC in line with the reference product Tambocor 50 mg
Tablets (MA number: PA2010/026/002; MAH: Mylan IRE
Healthcare Limited; dated September 2020). Consequentially,
the PIL has been updated.
Additional minor formatting updates to SmPC section 4.5 and
the PIL.
-
Changes: (Updated: 07 Aug 2024)
To update sections 4.3, 4.4, 4.5, 4.6, 4.9, 5.1, 5.2 and 5.3 of
the SmPC in line with the reference product Tambocor 50 mg
Tablets (MA number: PA2010/026/002; MAH: Mylan IRE
Healthcare Limited; dated September 2020). Consequentially,
the PIL has been updated.
Additional minor formatting updates to SmPC section 4.5 and
the PIL.
-
Changes: (Updated: 24 Nov 2023)
Description of update: To register M.3.2.P.7 Container Closure System for Aluminium (20μm) / PVC (250μm)-PVdC (60g/m2) blister packaging. The opportunity is taken to implement editorial updates to SmPC section 6.5: to remove details of heat seal lacquer; for Flecainide, correction from ''250 μm white rigid PVC/PVDC coated with 60gm-2 PVDC'' to ''250 μm white rigid PVC coated with 60gm-2 PVDC''.
SmPC Sections updated: 6.5 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload