SmPC- Amiodarone 100mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Amiodarone 100mg Tablets)
Last updated on this site: 29 Jul 2025
To update section 4.4 of the SmPC in line with the reference product Cordarone X 100 mg tablets, PL 7780/0586, MAH: Zentiva Pharma UK Limited, SPC updated 26/05/2022. Additionally, to make editorial changes to sections 4.4, 4.5 and 4.8 in line with the excipient guideline and QRD template. Consequently, the PIL is updated.
View Summary of Product Characteristics (SmPC- Amiodarone 100mg Tablets)
Last updated on this site: 29 Jul 2025
To update section 4.4 of the SmPC in line with the reference product Cordarone X 100 mg tablets, PL 7780/0586, MAH: Zentiva Pharma UK Limited, SPC updated 26/05/2022. Additionally, to make editorial changes to sections 4.4, 4.5 and 4.8 in line with the excipient guideline and QRD template. Consequently, the PIL is updated.
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Changes: (Updated: 29 Jul 2025)
To update section 4.4 of the SmPC in line with the reference product Cordarone X 100 mg tablets, PL 7780/0586, MAH: Zentiva Pharma UK Limited, SPC updated 26/05/2022. Additionally, to make editorial changes to sections 4.4, 4.5 and 4.8 in line with the excipient guideline and QRD template. Consequently, the PIL is updated.
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Changes: (Updated: 20 Sep 2022)
initial upload