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PIL - Betamethasone Valerate RD 0.025% w/w Cream: Change history

  • Description of update:

    To register addition of generic name - addition of INN name Betamethasone Valerate RD 0.025% w/w Cream to the MA. Consequentially, SPC sections 1, 4.1, 4.3, 4.4, 4.6, 4.7 and 4.9 and PIL and label have been updated. Also addition of `UK Only' (to cartons) for the Windsor framework. Additional changes: Topical corticosteroid updates to the labelling, PIL and SmPC at the request of the MHRA. Editorial amends are made: removal of the safety flash from the carton, addition of ‘Date of opening…..’ to the carton, replacement of the statement ‘Once opened, do not use this medicine for more than 3 months’ with ‘This medicine should be disposed of 3 months after first opening.’ on all pieces of artwork.

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

    • Changes: (Updated: 08 May 2024)

      Description of update:

      To register addition of generic name - addition of INN name Betamethasone Valerate RD 0.025% w/w Cream to the MA. Consequentially, SPC sections 1, 4.1, 4.3, 4.4, 4.6, 4.7 and 4.9 and PIL and label have been updated. Also addition of `UK Only' (to cartons) for the Windsor framework. Additional changes: Topical corticosteroid updates to the labelling, PIL and SmPC at the request of the MHRA. Editorial amends are made: removal of the safety flash from the carton, addition of ‘Date of opening…..’ to the carton, replacement of the statement ‘Once opened, do not use this medicine for more than 3 months’ with ‘This medicine should be disposed of 3 months after first opening.’ on all pieces of artwork.

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

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