FEMADEXIL (benzalkonium chloride), topical contraceptive

Insufficient clinical benefit for a topical contraceptive with regard to alternatives

• FEMADEXIL has marketing authorisation in topical contraception. This method reduces the risk of pregnancy without completely eliminating it. There are more effective alternatives for the risk of pregnancy.
• Given the numerous contraceptive alternatives already in existence, the medical need is covered and FEMADEXIL is not likely to provide an additional response.
• Given the available data, FEMADEXIL has a higher risk of HIV infection than the alternatives.