SmPC- Audavate / Betamethasone Valerate RD 0.025% w/w Cream: Change history
View Summary of Product Characteristics (SmPC- Audavate / Betamethasone Valerate 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.
SmPC Sections updated: 1, 4.1, 4.3, 4.4, 4.6, 4.7, 4.9 and 10.
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.
SmPC Sections updated: 1, 4.1, 4.3, 4.4, 4.6, 4.7, 4.9 and 10.
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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.
SmPC Sections updated: 1, 4.1, 4.3, 4.4, 4.6, 4.7, 4.9 and 10.
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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.
SmPC Sections updated: 1, 4.1, 4.3, 4.4, 4.6, 4.7, 4.9 and 10.
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Changes: (Updated: 20 Apr 2023)
Variation Description: To update section 4.4 of the SmPC in line with reference product Betnovate RD Cream (PL 10949/0021; MAH: Glaxo Wellcome UK Ltd., dated 26/05/2022). There are no consequential updates to the PIL.
SmPC sections updated – 4.4 and 10
No changes to artwork.
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Changes: (Updated: 20 Sep 2022)
Initial upload