PIL- Audavate RD 0.025% w/w Cream: Change history
View Patient Information Leaflet (PIL- Audavate RD 0.025% w/w Cream)
Last updated on this site: 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: Intro, 1, 2, 3, 4, 5 and 6.
Last updated on this site: 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: Intro, 1, 2, 3, 4, 5 and 6.
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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: Intro, 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 13 Oct 2023)
Description of update:
- To add the following MHRA recommended wording to section 1 of the PIL:
"Corticosteroid creams, ointments and other topical preparations come in four different strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent corticosteroid has a much stronger effect than a mild corticosteroid. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Audavate RD is classed as a potent corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition."
- To update the description in section 6 of the PIL by replacing the word "or" with "to".
PIL sections updated: 1 and 6.
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Changes: (Updated: 20 Sep 2022)
Initial upload