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Intended for UK patients and members of the public

Betamethasone Valerate 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

Betamethasone Valerate 0.1% w/w Ointment

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

Product Documentation

  • 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.

  • 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.

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

Betamethasone Valerate RD 0.025% w/w Cream

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

Product Documentation

  • 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.

  • 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: Title, intro, 1, 2, 3, 4, 5 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

Betamethasone Valerate RD 0.025% w/w Ointment

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

Product Documentation

  • 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: Title and introductory part and sections 1, 2, 3, 4, 5 and 6.

  • 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.

    SmPC Sections updated:

    0.025%: Sections 1, 4.1, 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 complaint

General FAQs

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