SmPC - Pentazocine Tablets BP 25mg: Change history
View Summary of Product Characteristics (SmPC - Pentazocine Tablets BP 25mg)
Last updated on this site: 02 Oct 2023
Description of update:
To update sections 4.2, 4.4, 4.7, 4.8, 5.1 and 5.3 of the SmPC in line with the reference product Pentazocine 25mg Tablets (PL: 11311/0529; MAH: Tillomed Laboratories Limited; Dated: 20/12/2022). Consequently, the PIL has been updated.
Additionally, editorial updates have been made to section 4.8 of the SmPC and the PIL, and the headings in sections 1, 7 and 4.8 of the SmPC and the PIL have been updated in line with the QRD template.
Furthermore, section 5.1 of the SmPC has been updated in line with the WHO ATC index and the PIL has been updated to align the excipient information for lactose with the latest EC Excipient guidelines.
SmPC sections updated: 1, 4.2, 4.4, 4.7, 4.8, 5.1, 5.3, 7 and 10.
Last updated on this site: 02 Oct 2023
Description of update:
To update sections 4.2, 4.4, 4.7, 4.8, 5.1 and 5.3 of the SmPC in line with the reference product Pentazocine 25mg Tablets (PL: 11311/0529; MAH: Tillomed Laboratories Limited; Dated: 20/12/2022). Consequently, the PIL has been updated.
Additionally, editorial updates have been made to section 4.8 of the SmPC and the PIL, and the headings in sections 1, 7 and 4.8 of the SmPC and the PIL have been updated in line with the QRD template.
Furthermore, section 5.1 of the SmPC has been updated in line with the WHO ATC index and the PIL has been updated to align the excipient information for lactose with the latest EC Excipient guidelines.
SmPC sections updated: 1, 4.2, 4.4, 4.7, 4.8, 5.1, 5.3, 7 and 10.
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Changes: (Updated: 02 Oct 2023)
Description of update:
To update sections 4.2, 4.4, 4.7, 4.8, 5.1 and 5.3 of the SmPC in line with the reference product Pentazocine 25mg Tablets (PL: 11311/0529; MAH: Tillomed Laboratories Limited; Dated: 20/12/2022). Consequently, the PIL has been updated.
Additionally, editorial updates have been made to section 4.8 of the SmPC and the PIL, and the headings in sections 1, 7 and 4.8 of the SmPC and the PIL have been updated in line with the QRD template.
Furthermore, section 5.1 of the SmPC has been updated in line with the WHO ATC index and the PIL has been updated to align the excipient information for lactose with the latest EC Excipient guidelines.
SmPC sections updated: 1, 4.2, 4.4, 4.7, 4.8, 5.1, 5.3, 7 and 10.
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Changes: (Updated: 21 Sep 2022)
Initial upload