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SmPC - Lofepramine 70mg Tablets: Change history

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  • View Summary of Product Characteristics (SmPC - Lofepramine 70mg Tablets)

    Last updated on this site: 15 Nov 2023

    Description of update: To update SmPC sections 4.3-4.9, 5.1-5.3 to align with reference product Lofepramine 70 mg Tablets (PL 17780/0998, MAH: Zentiva Pharma UK Limited, dated 14/04/2022). With consequential updates to the PIL. Additional updates to SmPC and PIL in line with the latest QRD template (version 10.3).

    SmPC Sections updated: 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5 .2, 5.3 and 10.

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    • Changes: (Updated: 15 Nov 2023)

      Description of update: To update SmPC sections 4.3-4.9, 5.1-5.3 to align with reference product Lofepramine 70 mg Tablets (PL 17780/0998, MAH: Zentiva Pharma UK Limited, dated 14/04/2022). With consequential updates to the PIL. Additional updates to SmPC and PIL in line with the latest QRD template (version 10.3).

      SmPC Sections updated: 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5 .2, 5.3 and 10.

    • Changes: (Updated: 06 Dec 2022)

      To update sections 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2 and 5.3 of the SmPC to bring in line with the reference product Lofepramine Rosemont 70mg/5ml Oral Suspension.

      SmPC section 4.4 has been updated to correct the excipient warning for lactose.

      The ADR statements in SmPC section 4.8 (and PIL section 4) have been updated in line with Appendix V (March 2021) of the QRD template, to include the information regarding the MHRA Yellow Card App.

       SmPC sections updated – 4.3, 4.4, 4.5, 4.6, 4.8, 5.1, 5.2, 5.3 and 10

      (PIL sections updated – Heading, 2, 4, 5 and 6)

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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