SmPC - Pentazocine Capsules BP 50mg: Change history
View Summary of Product Characteristics (SmPC - Pentazocine Capsules BP 50mg)
Last updated on this site: 04 Oct 2023
Description of update: To update SmPC sections 4.2, 4.4, 4.7, 4.8, 5.1, 5.3 in line with
the reference product Pentazocine 50mg Capsules (PL: 11311/0530; MAH: Tillomed Laboratories Limited; Dated: 20/12/2022). Consequently, the PIL has been updated.
Additionally, an ‘Excipients’ subheading has been added to SmPC section 4.4, editorial updates have been made to sections 4.7 and 4.8 of the SmPC and the PIL, and the headings in sections 1, 7, 4.8 and 10 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. The PIL has also been updated to align the excipient information for lactose with the latest EC Excipient guidelines, with the addition of the subheading ‘Information on sodium content’.
SmPC sections updated: 1, 4.2, 4.4, 4.7, 4.8, 5.1, 5.3, 7 and 10.
Last updated on this site: 04 Oct 2023
Description of update: To update SmPC sections 4.2, 4.4, 4.7, 4.8, 5.1, 5.3 in line with
the reference product Pentazocine 50mg Capsules (PL: 11311/0530; MAH: Tillomed Laboratories Limited; Dated: 20/12/2022). Consequently, the PIL has been updated.
Additionally, an ‘Excipients’ subheading has been added to SmPC section 4.4, editorial updates have been made to sections 4.7 and 4.8 of the SmPC and the PIL, and the headings in sections 1, 7, 4.8 and 10 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. The PIL has also been updated to align the excipient information for lactose with the latest EC Excipient guidelines, with the addition of the subheading ‘Information on sodium content’.
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: 04 Oct 2023)
Description of update: To update SmPC sections 4.2, 4.4, 4.7, 4.8, 5.1, 5.3 in line with
the reference product Pentazocine 50mg Capsules (PL: 11311/0530; MAH: Tillomed Laboratories Limited; Dated: 20/12/2022). Consequently, the PIL has been updated.
Additionally, an ‘Excipients’ subheading has been added to SmPC section 4.4, editorial updates have been made to sections 4.7 and 4.8 of the SmPC and the PIL, and the headings in sections 1, 7, 4.8 and 10 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. The PIL has also been updated to align the excipient information for lactose with the latest EC Excipient guidelines, with the addition of the subheading ‘Information on sodium content’.
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