PIL- Audavate RD 0.025% w/w Ointment: Change history
View Patient Information Leaflet (PIL- Audavate RD 0.025% w/w Ointment)
Last updated on this site: 03 May 2024
Description of update:
To register addition of generic INN name. Consequentially, the SPC has been updated:
PL 00142/1199 Audavate RD 0.025% w/w Ointment, Betamethasone Valerate RD 0.025% w/w Ointment: sections 1, 4.1, 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: Sections 1, 2, 3, 4, 5 and 6.
Last updated on this site: 03 May 2024
Description of update:
To register addition of generic INN name. Consequentially, the SPC has been updated:
PL 00142/1199 Audavate RD 0.025% w/w Ointment, Betamethasone Valerate RD 0.025% w/w Ointment: sections 1, 4.1, 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: Sections 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 03 May 2024)
Description of update:
To register addition of generic INN name. Consequentially, the SPC has been updated:
PL 00142/1199 Audavate RD 0.025% w/w Ointment, Betamethasone Valerate RD 0.025% w/w Ointment: sections 1, 4.1, 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: Sections 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 24 May 2023)
N/A
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Changes: (Updated: 01 Dec 2022)
Correct PIL uploaded
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Changes: (Updated: 20 Sep 2022)
Initial upload