SmPC - Imatinib Accord 400 mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Imatinib Accord 400 mg Film-coated Tablets)
Last updated on this site: 17 Jun 2026
Update to sections 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 of the SmPC and sections 1, 2, 3 of the leaflet to bring in line with the reference product, Glivec film-coated tablets, PLGB 00101/1080.
SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3 and 10
Variation approval date: 12/06/206
Last updated on this site: 17 Jun 2026
Update to sections 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 of the SmPC and sections 1, 2, 3 of the leaflet to bring in line with the reference product, Glivec film-coated tablets, PLGB 00101/1080.
SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3 and 10
Variation approval date: 12/06/206
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Changes: (Updated: 17 Jun 2026)
Update to sections 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 of the SmPC and sections 1, 2, 3 of the leaflet to bring in line with the reference product, Glivec film-coated tablets, PLGB 00101/1080.
SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3 and 10
Variation approval date: 12/06/206
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Changes: (Updated: 05 Nov 2024)
1)To register a change in the composition of the finished
product by changing the tablet coating from Hypromellose 6
cps (E464) to Polyvinyl alcohol- (E1203) and from Polyethylene
glycol to Polyethylene glycol (E1521). Consequently, section
6.1 of the SmPC and the PIL has been updated.
2)To register a minor change in manufacturing process of
finished product by changing the manufacturing process for
coating solution preparation from non-aqueous coating solution to aqueous coating solution.
3)To register a change in the specification parameters of the
finished product by deletion of residual solvent test for
Dichloromethane from finished product specification.
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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