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PIL - Diazepam 2mg, 5mg, 10mg Tablets: Change history

  • Description of update: To update section 6.1 of the SmPC and section 6 of the PIL by adding a missing excipient - pregelatinised maize starch. Minor editorial changes are also made to the PIL to correct typographical errors.

    PIL sections updated:  4 and 6.

    • Changes: (Updated: 26 Oct 2023)

      Description of update: To update section 6.1 of the SmPC and section 6 of the PIL by adding a missing excipient - pregelatinised maize starch. Minor editorial changes are also made to the PIL to correct typographical errors.

      PIL sections updated:  4 and 6.

    • Changes: (Updated: 23 Jun 2023)

      Variation Description: To update the PIL to bring in line with the QRD template (version 10.3) and to bring in line with the SmPC. Update to the PIL lactose excipient wording in line with the latest EC Excipient Guidance (version 10.2). Update to ATC code in SmPC section 5.1, in line with the WHO ATC Index. Additional QRD updates to SmPC sections 1, 3, 4.1, 4.2 (10mg only), 5.1, 6.1, 6.6 (2mg only), 7 (2mg only), 8 (2mg only), 9 (2mg only) and 10 (2mg only). Additional minor typographical and editorial changes to the PIL as well as to SmPC sections 1, 2, 3, 4.1, 4.2, 4.4, 4.5, 4.7, 5.2 (5mg only) and 6.1 (2 & 5mg only).

      PIL sections updated – 2, 3, 4, 5 and 6.

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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