SmPC - Deferasirox Accord 360 mg Film-coated Tablets: Change history

Update to section 4.2 of the SmPC in line with the reference product, EXJADE 90/180/360 mg film-coated tablets; MAH: Novartis Europharm Limited, Ireland.

Editorial changes have been made to sections 4.4, 4.8 and 5.2 of SmPC in line with the reference product information.

SmPC sections updated: 4.2, 4.4, 4.8, 5.2 and 10.

Update to section 4.2 of the SmPC in line with the reference product, EXJADE 90/180/360 mg film-coated tablets; MAH: Novartis Europharm Limited, Ireland.

Editorial changes have been made to sections 4.4, 4.8 and 5.2 of SmPC in line with the reference product information.

SmPC sections updated: 4.2, 4.4, 4.8, 5.2 and 10.

Description of update:

1. To update the Risk Management Plan to RMP Version 6.0.

2. To update sections 4.2, 5.1 and 5.2 of the SmPC in line with reference product information (EXJADE 90/180/360 mg film coated tablets with procedure outcome of EMEA/H/C/000670/II/0082/G & MAH: Novartis Europharm Limited; Ireland). Consequently, the Patient Information Leaflet has also been updated.

SmPC sections updated: 4.2. 4.4, 4.8, 5.1, 5.2, 10.