Vaniqa
Authorised
This medicine is authorised for use in the European Union
eflornithine
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR) for Vaniqa. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Vaniqa.
Vaniqa is a white cream that contains the active substance eflornithine (115 mg).
Vaniqa is used for the treatment of facial hirsutism in women. Facial hirsutism is excessive growth on the face of coarse hair, often in a male pattern.
The medicine can only be obtained with a prescription.
Vaniqa is applied to clean and dry affected areas of the face and under the chin twice a day (at least eight hours apart). It is applied in a thin layer and rubbed in thoroughly.
Improvements may be noticed within eight weeks of starting treatment. Continued treatment is needed to maintain the beneficial effects and may lead to further improvement. Vaniqa should be stopped if no improvements are noticed within four months of starting treatment.
Women using Vaniqa may still need to use other means to remove hair (plucking, shaving).
The active substance in Vaniqa, eflornithine, works by blocking the action of an enzyme called ornithine decarboxylase. This enzyme is found in the bulb of the hair follicle where it controls hair production. When this enzyme is blocked, the growth of hair is slowed down.
Vaniqa has been studied in two clinical trials involving 596 women treated for up to 24 weeks with Vaniqa or placebo (a dummy treatment, in this case the cream without any active substance).
The effectiveness of the treatment was assessed at the end of the study by a doctor who graded the hirsutism as ‘clear / almost clear’, ‘marked improvement’, ‘improved’ or ‘no improvement / worse’, 48 hours after women had shaved the treated areas of the face and under the chin.
Improvement was seen as early as eight weeks after starting treatment. In both studies, significant improvement was seen with Vaniqa compared with placebo. When the results were combined, a successful outcome (graded as ‘clear / almost clear’ or ‘marked improvement’) was seen in 35% of the women treated with Vaniqa, compared with 9% of those treated with placebo.
The most common side effect with Vaniqa (seen in more than 1 patient in 10) is acne. For the full list of all the side effects reported with Vaniqa, see the package leaflet.
Vaniqa should not be used in people who may be hypersensitive (allergic) to eflornithine or any of the other ingredients.
The CHMP decided that Vaniqa’s benefits are greater than its risks and recommended that it be given marketing authorisation.
The European Commission granted a marketing authorisation valid throughout the European Union, for Vaniqa on 20 March 2001. The marketing authorisation is valid for an unlimited period.
For more information about treatment with Vaniqa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: N/0057
26/09/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Vaniqa
- Active substance
- Eflornithine
- International non-proprietary name (INN) or common name
- eflornithine
- Therapeutic area (MeSH)
- Hirsutism
- Anatomical therapeutic chemical (ATC) code
- D11AX
Pharmacotherapeutic group
Other dermatological preparationsTherapeutic indication
Treatment of facial hirsutism in women.
Topics
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