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SmPC - Zopiclone 7.5mg Tablets: Change history

  • To delete PVC/PVDC/Al (250μm/40g/m2/20μm) blister pack of the Finished product. Consequently, section 6.5 of the SmPC is updated.

    • Changes: (Updated: 15 Aug 2024)

      To delete PVC/PVDC/Al (250μm/40g/m2/20μm) blister pack of the Finished product. Consequently, section 6.5 of the SmPC is updated.

    • Changes: (Updated: 08 Apr 2024)

      Description of update: To update sections 4.3, 4.4, 4.8, 5.1 and 5.2 of the SmPC in line with reference product, Zimovane LS 3.75 mg, 7.5mg film-coated tablets, PL 04425/0625, 0624 MAH: Aventis Pharma Limited (Sanofi). Consequently, the leaflet has been updated. Additional updates have been made to the SmPC and PIL to correct QRD wording, in line with the QRD template (Version 10.3), spelling, punctuation and grammar.

      SmPC Sections updated: 4.3, 4.4, 4.8, 5.1, 5.2 and 10.

    • Changes: (Updated: 07 Jun 2023)

      Website administration update

    • Changes: (Updated: 22 Sep 2022)

      Initial upload

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