SmPC - Imatinib Accord 100 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Imatinib Accord 100 mg Film-coated Tablets)
Last updated on this site: 15 Aug 2024
To update sections 4.4, 5.1 and 5.2 of the SmPC in line with reference product, Glivec (MAH: Novartis Europharm Limited, Ireland). Consequently, the PIL has been updated.
Last updated on this site: 15 Aug 2024
To update sections 4.4, 5.1 and 5.2 of the SmPC in line with reference product, Glivec (MAH: Novartis Europharm Limited, Ireland). Consequently, the PIL has been updated.
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Changes: (Updated: 15 Aug 2024)
To update sections 4.4, 5.1 and 5.2 of the SmPC in line with reference product, Glivec (MAH: Novartis Europharm Limited, Ireland). Consequently, the PIL has been updated.
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Changes: (Updated: 17 Oct 2023)
Description of update:
1. To register the addition of a new pack size of Alu/Alu-blister pack of 30s (30 x 1) for the finished product
2. To register the addition of a new pack size of Alu/Alu-blister pack of 60s (60 x 1) for the finished product.
3. To register the addition of a new pack size of Alu/Alu-blister pack of 90s (90 x 1) for the finished product.
4. To register the addition of a new pack size of Alu/Alu-blister pack of 120s (120 x 1) for the finished product.
5. To register the addition of a new pack size of Alu/Alu-blister pack of 180s (180 x 1) for the finished product.
SmPC sections updated: 6.5 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload