SmPC - Reltebon 80mg Prolonged-release Tablets: Change history

Last updated on this site: 25 Sep 2024

Child-resistant blister pack (PVC/PVdC/Al/PET/paper) removed from SmPC 6.5.

Changes: (Updated: 25 Sep 2024)

Child-resistant blister pack (PVC/PVdC/Al/PET/paper) removed from SmPC 6.5.
Changes: (Updated: 08 Apr 2024)

Description of update: To update sections 4.4 and 4.8 of the SPC, and sections 2 and 4 of the PIL to bring in line with PSUSA/00002254/202304 for Oxycodone and risk of SOD. In addition, editorial updates have been made to the PIL.
SmPC Sections updated: 4.4, 4.8 and 10.
Changes: (Updated: 18 May 2023)

Variation Description: SmPC sections 4.2, 4.4, 4.8, 4.9 and the PIL have been updated in line with the PRAC recommendation (PSUSA/00002254/202204) regarding opioid use disorder. PIL section 6 has also been updated to reword the section “What Reltebon looks like and contents of the pack”.
SmPC sections updated – 4.2, 4.4, 4.8, 4.9 and 10.
Changes: (Updated: 21 Sep 2022)

Initial upload

Changes: (Updated: 25 Sep 2024)