SmPC - Verapamil Tablets BP 120mg: Change history
View Summary of Product Characteristics (SmPC - Verapamil Tablets BP 120mg)
Last updated on this site: 06 Jul 2023
Variation Description:
1) To update sections 4.3 and 4.8 of the SmPC and to update the PIL in line with the reference product (Securon SR 240mg Tablets, PL 46302/0027, MAH: Mylan Generics, SPC updated 05/08/2022).
2) To update section 4.4 of the SmPC and to update the PIL section 2 to include the sodium free statement, in line with the latest EC guidelines on excipients (EMA/CHMP/302620/2017). The cartons have been updated to remove non-compulsory excipients.
Additional updates have been made to the PIL to align the information with the SmPC and to bring in line with the latest QRD template (Version 10.3, 09/2022).
Last updated on this site: 06 Jul 2023
Variation Description:
1) To update sections 4.3 and 4.8 of the SmPC and to update the PIL in line with the reference product (Securon SR 240mg Tablets, PL 46302/0027, MAH: Mylan Generics, SPC updated 05/08/2022).
2) To update section 4.4 of the SmPC and to update the PIL section 2 to include the sodium free statement, in line with the latest EC guidelines on excipients (EMA/CHMP/302620/2017). The cartons have been updated to remove non-compulsory excipients.
Additional updates have been made to the PIL to align the information with the SmPC and to bring in line with the latest QRD template (Version 10.3, 09/2022).
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Changes: (Updated: 06 Jul 2023)
Variation Description:
1) To update sections 4.3 and 4.8 of the SmPC and to update the PIL in line with the reference product (Securon SR 240mg Tablets, PL 46302/0027, MAH: Mylan Generics, SPC updated 05/08/2022).
2) To update section 4.4 of the SmPC and to update the PIL section 2 to include the sodium free statement, in line with the latest EC guidelines on excipients (EMA/CHMP/302620/2017). The cartons have been updated to remove non-compulsory excipients.
Additional updates have been made to the PIL to align the information with the SmPC and to bring in line with the latest QRD template (Version 10.3, 09/2022).
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Changes: (Updated: 10 May 2023)
Single Variation
Variation type: IB, B.II.e.1.z
Variation Description: To register a module 32p7 covering the PVC blister lidded with aluminium. SmPC section 6.5 has been updated deleting obsolete packing.
Note: Additionally, details of heat seal lacquer have been removed from SmPC Section 6.5.
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Changes: (Updated: 22 Sep 2022)
Initial upload