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PIL- Audavate 0.1% w/w Ointment (PL 0142/1200): Change history

  • Description of update:

    To register addition of generic INN name. Consequentially, the SPC has been updated:

    PL 00142/1200 Audavate 0.1% w/w Ointment, Betamethasone Valerate 0.1% w/w Ointment: sections: 1, 4.2, 4.3 and 4.4.

    Consequently, the PIL and label have been updated. Additionally, addition of `UK Only' (to cartons) for the Windsor framework requirements.

    Additional changes:

    Cartons and Labels: ‘Strong steroid’ added in line with MHRA Letter (15/01/24).

    PIL Section 2: updated to include paragraph about potency of a topical corticosteroids, in line with MHRA Letters (08/08/23 and 15/01/24).

    PIL Section 3: steroid withdrawal reaction under ‘Not known’ has been updated in line with MHRA Letter (06/11/23).

    SmPC Section 4.4 updated in line with MHRA Letters (06/11/23 and 15/01/24). Editorial changes to the cartons and PIL.

    PIL sections updated: 1, 2, 3, 4, 5 and 6.

    • Changes: (Updated: 03 May 2024)

      Description of update:

      To register addition of generic INN name. Consequentially, the SPC has been updated:

      PL 00142/1200 Audavate 0.1% w/w Ointment, Betamethasone Valerate 0.1% w/w Ointment: sections: 1, 4.2, 4.3 and 4.4.

      Consequently, the PIL and label have been updated. Additionally, addition of `UK Only' (to cartons) for the Windsor framework requirements.

      Additional changes:

      Cartons and Labels: ‘Strong steroid’ added in line with MHRA Letter (15/01/24).

      PIL Section 2: updated to include paragraph about potency of a topical corticosteroids, in line with MHRA Letters (08/08/23 and 15/01/24).

      PIL Section 3: steroid withdrawal reaction under ‘Not known’ has been updated in line with MHRA Letter (06/11/23).

      SmPC Section 4.4 updated in line with MHRA Letters (06/11/23 and 15/01/24). Editorial changes to the cartons and PIL.

      PIL sections updated: 1, 2, 3, 4, 5 and 6.

    • Changes: (Updated: 24 May 2023)

      N/A

    • Changes: (Updated: 24 May 2023)

      N/A

    • Changes: (Updated: 20 Sep 2022)

      Initial upload

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