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: 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.
Last updated on this site: 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.
-
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.
-
Changes: (Updated: 20 Sep 2022)
Initial upload