SmPC- Amlodipine 5mg Tablets (PL 20075/0129): Change history
View Summary of Product Characteristics (SmPC- Amlodipine 5mg Tablets (PL 20075/0129))
Last updated on this site: 20 Jun 2025
Description of update: To update sections 4.4, 4.5 and 4.8 of the SmPC in line with the reference product Istin 5 mg tablets. Consequently, the PIL has been updated. In addition; there are editorial updates to SmPC section 4.8 and the PIL, there are also QRD updates to the PIL.
SmPC sections updated: 4.4, 4.5, 4.8 and 10.
Last updated on this site: 20 Jun 2025
Description of update: To update sections 4.4, 4.5 and 4.8 of the SmPC in line with the reference product Istin 5 mg tablets. Consequently, the PIL has been updated. In addition; there are editorial updates to SmPC section 4.8 and the PIL, there are also QRD updates to the PIL.
SmPC sections updated: 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 20 Jun 2025)
Description of update: To update sections 4.4, 4.5 and 4.8 of the SmPC in line with the reference product Istin 5 mg tablets. Consequently, the PIL has been updated. In addition; there are editorial updates to SmPC section 4.8 and the PIL, there are also QRD updates to the PIL.
SmPC sections updated: 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 20 Jun 2025)
To update sections 4.4, 4.5 and 4.8 of the SmPC in line with the reference product Istin 5 mg tablets. Consequently, the PIL has been updated. In addition; there are editorial updates to SmPC section 4.8 and the PIL, there are also QRD updates to the PIL.
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Changes: (Updated: 02 Nov 2023)
Description of update: To update sections 2, 4.3, 4.4, 4.5, 4.8 and 5.1 of the SmPC in line with current guidance and the reference product Istin Tablets. Consequentially, the PIL has been updated.
SmPC sections updated: 2, 4.3, 4.4, 4.5, 4.8, 5.1 and 10.
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Changes: (Updated: 24 May 2023)
Name updated
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Changes: (Updated: 20 Sep 2022)
initial upload