SmPC- Topiramate Accord 100mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC- Topiramate Accord 100mg Film-coated Tablets)
Last updated on this site: 18 Sep 2023
Description of update: The following change(s) has been notified:
Type IAin: B.II.f).1.a).1 Stability - Change in the shelf-life or storage conditions of the finished product. Reduction of the shelf life of the finished product - As packaged for sale
Reduction of shelf life of the finished product from 24 months to 18 months for Topiramate 25/50/100/200 mg Film-coated Tablets.
SmPC sections updated: 4.2, 4.4, 4.5, 4.7, 5.1, 6.3 and 10.
Last updated on this site: 18 Sep 2023
Description of update: The following change(s) has been notified:
Type IAin: B.II.f).1.a).1 Stability - Change in the shelf-life or storage conditions of the finished product. Reduction of the shelf life of the finished product - As packaged for sale
Reduction of shelf life of the finished product from 24 months to 18 months for Topiramate 25/50/100/200 mg Film-coated Tablets.
SmPC sections updated: 4.2, 4.4, 4.5, 4.7, 5.1, 6.3 and 10.
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Changes: (Updated: 18 Sep 2023)
Description of update: The following change(s) has been notified:
Type IAin: B.II.f).1.a).1 Stability - Change in the shelf-life or storage conditions of the finished product. Reduction of the shelf life of the finished product - As packaged for sale
Reduction of shelf life of the finished product from 24 months to 18 months for Topiramate 25/50/100/200 mg Film-coated Tablets.
SmPC sections updated: 4.2, 4.4, 4.5, 4.7, 5.1, 6.3 and 10.
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Changes: (Updated: 11 May 2023)
Description of update: The proposed change is: C.I.2.a; Change(s) in the Summary of Product Characteristics, Labelling or Package Leaflet of a generic/hybrid/biosimilar medicinal products following assessment of the same change for the reference product; Implementation of change(s) for which no new additional data is required to be submitted by the MAH - variation to update SmPC and PIL information in line with the product information of reference product (Topamax 25mg, 50mg, 100mg and 200mg tablets with Procedure reference number: SE/H/0110/001-009
The date of approval is 04-MAY-2023.
SmPC sections updated: 4.2, 4.4, 4.5, 5.1, 10.
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Changes: (Updated: 09 Nov 2022)
Updated
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Changes: (Updated: 22 Sep 2022)
initial upload