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More information for hcps and patients prescribed Winlevi®

Get more services and resources about acne vulgaris and WINLEVI® for you and your patients.

Summary of Product Characteristics

https://www.medicines.org.uk/emc/product/100519/smpc

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Patient Information Leaflet

https://www.medicines.org.uk/emc/files/pil.100519.pdf

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Public Assessment Report

files/download/Public-Assessment-Report-PL25258-0425.pdf

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Indication

WINLEVI® (clascoterone) 10 mg/g cream is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.2

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Glenmark Pharmaceuticals Europe Ltd medical_information@glenmarkpharma.com or call 0800 458 0383.

References

  1. Rosette C, et al. J Drugs Dermatol. 2019;18(5):412-418.
  2. WINLEVI® SPC.
  3. Eichenfield LF, et al. J Drugs Dermatol. 2024;23(1):1278-1283.
  4. Purdy S, DeBerker D. BMJ Clin Evid. 2008;1714.
  5. Zouboulis CC, Bettoli V. Br J Dermatol. 2015;Suppl 1:27-36.
  6. ONS. Estimates of the population for the UK, England, Wales, Scotland and Northern Ireland. Accessed 27 June 2024. https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/populationestimatesforukenglandandwalesscotlandandnorthernireland.
  7. Primary Care Dermatology Society. Acne: acne vulgaris. Accessed 27 June 2024. https://www.pcds.org.uk/clinical-guidance/acne-vulgaris.
  8. Dawson AL, et al. BMJ. 2013;346:f2634.
  9. Layton AM, Thiboutot D, Tan J. Br J Dermatol. 2021;184(2):219-225.
  10. Morshed ASM, et al. Sci Rep. 2023; 13: 21084.
  11. Baldwin, H et al. J Drugs Dermatol. 2023;22(6):582-587.
  12. Del Rosso JQ, Kircik L. J Dermatolog Treat. 2024;35(1):2298878.
  13. Kurokawa I, et al. Dermatol Ther (Heidelb). 2021;11(4):1129-1139.
  14. Tuchayi S, et al. Acne vulgaris. Nat Rev Dis Primers. 2015; 1:15029.
  15. Kim HJ, et al. Int J Mol Sci. 2024;25(10):5302.
  16. Hebert A, et al. J Drugs Dermatol. 2023;22(2):174-181.
  17. Hebert A, et al. JAMA Dermatol. 2020;156(6):621-630.
  18. Abelson MB, Fink K. (2003). Controlling for the Placebo Effect. Review of Ophthalmology. Accessed October 2024.
  19. Hebert A, et al. JAMA Dermatology. 2020;156(6):621-630 (Supplement 1).
  20. Eichenfield L, et al. J Am Acad Dermatol. 2020;83(2):477-485.
  21. Mazzetti A, et al. J Drugs Dermatol. 2019;18(6):563.
  22. NICE Clinical Knowledge Summary. Acne vulgaris.

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