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eflornithine

Vaniqa · ATC code D11AX

Also known as: Eflornithin

Key facts
Active substance
eflornithine
ATC code
D11AX
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Vaniqa 11.5% cream
Marketing authorisation holder
Almirall, S.A.
Information as of
2026-10-27

Key facts

Eflornithine is an ornithine decarboxylase inhibitor for use on the skin (cream). It is used to treat facial hirsutism in women.

What it is used for

  • Facial hirsutism in women

Dosing

  • Apply a thin layer of cream to affected areas twice daily, at least eight hours apart, and rub in thoroughly
  • Efficacy shown only for the face and under the chin; limit application to these areas
  • Improvement may be seen within eight weeks; continued use is needed to maintain the effect
  • Discontinue if no benefit within four months
  • After shaving or other hair removal wait at least five minutes before applying; do not cleanse the area for four hours
  • Elderly: no dose adjustment; no data in children and adolescents

Contraindications

  • Hypersensitivity to the active substance or any excipient

Important warnings

  • Excessive hair growth can result from serious underlying disorders (e.g. polycystic ovary syndrome, androgen-secreting neoplasm) or certain medicines
  • For cutaneous use only; avoid contact with eyes and mucous membranes
  • If irritation develops, reduce application temporarily to once a day; stop if irritation continues
  • Contains cetostearyl alcohol, stearyl alcohol and parabens, which may cause skin or allergic reactions
  • Caution in severe renal impairment (not studied)

Side effects

  • Very common: acne (generally mild)
  • Common: pseudofolliculitis barbae, alopecia, burning, stinging and tingling skin, dry skin, pruritus, erythema, rash, folliculitis
  • Reactions are mostly mild and usually resolve without stopping treatment

Interactions

  • No interaction studies have been performed

Pregnancy and breastfeeding

  • Women who are pregnant or planning pregnancy should use an alternative means to manage facial hair
  • Not to be used while breastfeeding

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • VaniqaAlmirall, S.A. · EMEA/H/C/000325

Source: European Medicines Agency (EMA), product information

Brand names in 4 more European countries
France
Ornidyl
Iceland
Vaniqa
Liechtenstein
Vaniqa
Norway
Vaniqa

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

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Sources

  1. European Medicines Agency. Vaniqa – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/vaniqa-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.