Intended for UK patients and members of the public
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintProduct Documentation
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 00142/1200 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: Title and introductory part and 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 00142/1200 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.
SmPC Sections updated:
0.1%: Sections 1, 4.2, 4.3, 4.4 and 10.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintFor any further assistance, please get in touch.