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EMA guidance · 2013-01-30

European Medicines Agency update on Diane 35 and generics used in the treatment of acne

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Summary

EMA provides an update on Diane-35 and generic versions used for acne, outlining regulatory considerations and implications for safety and labeling.

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Diseases / indications

Drugs mentioned

  • Diane-35 (ethinylestradiol / cyproterone acetate)
  • generic versions used for acne