PIL - Deferasirox 90 mg, 180 mg, 360 mg Film-coated Tablets: Change history
View Patient Information Leaflet (PIL - Deferasirox 90 mg, 180 mg, 360 mg Film-coated Tablets)
Last updated on this site: 03 Jul 2023
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.
PIL sections updated: 3, 6.
Last updated on this site: 03 Jul 2023
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.
PIL sections updated: 3, 6.
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Changes: (Updated: 03 Jul 2023)
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.
PIL sections updated: 3, 6.
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Changes: (Updated: 22 Sep 2022)
Initial upload