SmPC - Ibandronic acid 50mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Ibandronic acid 50mg Film-coated Tablets)
Last updated on this site: 08 Aug 2025
Description of update: To update sections 4.4, 4.5, 4.6, 4.8 and 5.2 of the SmPC in line with the reference product Bondronat 50 mg film-coated tablets (MA number: PLGB 43252/0020; MAH: Atnahs Pharma UK Limited, Dated: 28/03/2024). Consequently, the PIL has been updated. Additionally, editorial and formatting updates have been made to the SmPC and PIL, the PIL has been updated in line with latest QRD template and the tablet description in section 6 of the PIL has been aligned with section 3 of the SmPC.
Date of approval: 27/06/2025
SmPC sections updated: 4.4, 4.5, 4.6, 4.8, 5.2 and 10
Last updated on this site: 08 Aug 2025
Description of update: To update sections 4.4, 4.5, 4.6, 4.8 and 5.2 of the SmPC in line with the reference product Bondronat 50 mg film-coated tablets (MA number: PLGB 43252/0020; MAH: Atnahs Pharma UK Limited, Dated: 28/03/2024). Consequently, the PIL has been updated. Additionally, editorial and formatting updates have been made to the SmPC and PIL, the PIL has been updated in line with latest QRD template and the tablet description in section 6 of the PIL has been aligned with section 3 of the SmPC.
Date of approval: 27/06/2025
SmPC sections updated: 4.4, 4.5, 4.6, 4.8, 5.2 and 10
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Changes: (Updated: 08 Aug 2025)
Description of update: To update sections 4.4, 4.5, 4.6, 4.8 and 5.2 of the SmPC in line with the reference product Bondronat 50 mg film-coated tablets (MA number: PLGB 43252/0020; MAH: Atnahs Pharma UK Limited, Dated: 28/03/2024). Consequently, the PIL has been updated. Additionally, editorial and formatting updates have been made to the SmPC and PIL, the PIL has been updated in line with latest QRD template and the tablet description in section 6 of the PIL has been aligned with section 3 of the SmPC.
Date of approval: 27/06/2025
SmPC sections updated: 4.4, 4.5, 4.6, 4.8, 5.2 and 10
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Changes: (Updated: 14 Apr 2023)
Variation Description: To update SmPC sections 2, 4.4, 4.5, 4.8 and 6.1. Sections 2 and 4.4 have been updated in line with the EC guidelines on Excipients (EMA/CHMP/302620/2017) for lactose and sodium; Section 4.5 has been updated to correct the spelling of `Ph' to `pH'; Section 4.8 and leaflet have been updated in line with EMA National ADR reporting system wording for the UK; Section 6.1 has been updated to correct the spelling of `sylica' to `silica' in line with module 3 M.3.2.P.1. Consequently, the PIL has been updated. Additionally, the wording on how to take with food has been updated in PIL section 3 to improve readability. The active substance wording in PIL section 6 has been updated to align with SmPC section 2, as well as an update to the tablet description to align with SmPC section 3. The PIL has been updated throughout to align with the latest QRD template as well as the correction of grammar and spelling.
SmPC sections updated – 2, 4.4, 4.5, 4.8, 6.1 and 10.
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Changes: (Updated: 20 Sep 2022)
Initial upload