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SmPC - Paroxetine 10mg Film-coated Tablets: Change history

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  • View Summary of Product Characteristics (SmPC - Paroxetine 10mg Film-coated Tablets)

    Last updated on this site: 05 Jan 2024

    Description of update: To update SmPC section 4.8 and PIL in line with PRAC (PSUSA/00002319/202212) recommendation to add ADR leukopenia.

    SmPC Sections updated: 4.8 and 10.

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    • Changes: (Updated: 05 Jan 2024)

      Description of update: To update SmPC section 4.8 and PIL in line with PRAC (PSUSA/00002319/202212) recommendation to add ADR leukopenia.

      SmPC Sections updated: 4.8 and 10.

    • Changes: (Updated: 14 Sep 2023)

      To update sections 4.3, 4.4, 4.5 and 5.1 of the SmPC in line with reference product, Seroxat 10mg film-coated tablets, PL 10592/0218, MAH: SmithKline Beecham Limited. Consequently, the Patient Information Leaflet has been updated.

      Additional grammatical and formatting changes were made to the PIL to aid readability.

    • Changes: (Updated: 21 Sep 2022)

      Initial upload

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