SmPC - Amoxicillin 500 mg Capsules BP: Change history
View Summary of Product Characteristics (SmPC - Amoxicillin 500 mg Capsules BP)
Last updated on this site: 15 Aug 2024
IB C.I.2.a:
To update sections 4.4, 4.8, and 5.1 of the SmPC in line with the reference product, Amoxil Capsules 500 mg. Consequently, the PIL has been updated. Additionally, section 2 for Amoxicillin 250 mg Capsules BP, as well as sections 4.4, 4.8, and 5.1 of the SmPC for both Amoxicillin 250 mg and 500 mg Capsules BP, have been updated with editorial updates, updates in line with the QRD template and the EC Excipient Guidelines.
IB C.I.3.a:
To update section 5.1 of the SmPC in line with EMA guidance to relocate MIC data from the product information.
Last updated on this site: 15 Aug 2024
IB C.I.2.a:
To update sections 4.4, 4.8, and 5.1 of the SmPC in line with the reference product, Amoxil Capsules 500 mg. Consequently, the PIL has been updated. Additionally, section 2 for Amoxicillin 250 mg Capsules BP, as well as sections 4.4, 4.8, and 5.1 of the SmPC for both Amoxicillin 250 mg and 500 mg Capsules BP, have been updated with editorial updates, updates in line with the QRD template and the EC Excipient Guidelines.
IB C.I.3.a:
To update section 5.1 of the SmPC in line with EMA guidance to relocate MIC data from the product information.
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Changes: (Updated: 15 Aug 2024)
IB C.I.2.a:
To update sections 4.4, 4.8, and 5.1 of the SmPC in line with the reference product, Amoxil Capsules 500 mg. Consequently, the PIL has been updated. Additionally, section 2 for Amoxicillin 250 mg Capsules BP, as well as sections 4.4, 4.8, and 5.1 of the SmPC for both Amoxicillin 250 mg and 500 mg Capsules BP, have been updated with editorial updates, updates in line with the QRD template and the EC Excipient Guidelines.
IB C.I.3.a:
To update section 5.1 of the SmPC in line with EMA guidance to relocate MIC data from the product information.
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Changes: (Updated: 07 Nov 2023)
Description of update: To update sections 4.1 and 5.1 of the SmPC and sections 2 and 6 of PIL in line with the reference product information Amoxil (PL 00038/0105).
SmPC sections updated: 4.1, 5.1 and 10.
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Changes: (Updated: 22 Jun 2023)
Description of update: To update sections 4.4, 4.8, and 4.9 of the SmPC and sections 2 and 4 of PIL in line with the PRAC recommendation on the PSUSA change for Amoxicillin(PSUSA/00000187/202203).
SmPC sections updated: 4.4, 4.8, 4.9, 10.
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Changes: (Updated: 26 May 2023)
Website administration update; no change to file.
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Changes: (Updated: 09 Nov 2022)
Updated
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Changes: (Updated: 20 Sep 2022)
Linked to amended product entry
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Changes: (Updated: 15 Sep 2022)
Initial upload
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Changes: (Updated: 15 Sep 2022)
Initial upload