SmPC - Imatinib Accord 400 mg Film-coated Tablets: Change history

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.

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.