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Winlevi (clascoterone)
Australian Prescription Medicine Decision Summary
Published
Product name
Winlevi
Active ingredient
Clascoterone
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Winlevi (clascoterone 1% w/w cream tube) was approved for the following therapeutic use:
Winlevi (clascoterone) cream is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
How this medicine works
Winlevi is a cream for acne that blocks androgen receptors. How it works is unclear. It may compete with the androgen dihydrotestosterone for the same receptors in the oil (sebaceous) glands and hair follicles. This reduces the signals that cause acne.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Winlevi was considered favourable for the therapeutic use approved.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
ARTG details
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.