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Intended for UK patients and members of the public

Audavate 0.1% w/w Cream

PL Number:
0142/0924
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

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 complaint

Audavate 0.1% w/w Ointment

PL Number:
0142/1200
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

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 complaint

Audavate RD 0.025% w/w Cream

PL Number:
0142/1198
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

     

  • 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.

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 complaint

Audavate RD 0.025% w/w Ointment

PL Number:
0142/1199
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

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 complaint

General FAQs

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