12 July 2007 - YAZ approved in the Netherlands as European Reference Member State
YAZ is the newest oral contraceptive innovation from Bayer Schering Pharma
Berlin — Bayer Schering Pharma AG, Germany, announced today that the Dutch regulatory authorities have granted national approval for their new low dose 24-day oral contraceptive YAZ® in the Netherlands.
YAZ will be registered for the indications oral contraception and the treatment of moderate acne in women seeking contraception. The Netherlands will serve as the Reference Member State for the upcoming Mutual Recognition Procedure to gain European-wide marketing approval for the product.
“We are very excited about this first European approval for YAZ. YAZ is the first oral contraceptive to combine the unique progestin drospirenone with 20 mcg of ethinyl estradiol in a 24-day active hormone pill regimen. Through its innovative active ingredient drospirenone, YAZ offers additional benefits, such as the treatment of acne, to women who want reliable birth control,” said Phil Smits, M.D., Head of the business unit Women’s Healthcare.
YAZ, which has been available in the U.S. since April 2006, is the fastest-growing oral contraceptive brand in the U.S. YAZ is also the only oral contraceptive with clinically proven efficacy in the treatment of the emotional and physical symptoms associated with PMDD (Premenstrual Dysphoric Disorder), such as mood swings, irritability, anxiety, changes in appetite and eating habits, breast tenderness, bloating, and headache. YAZ was granted this indication in the USA in October 2006. Bayer Schering Pharma AG plans to proceed with the application for the registration of the PMDD indication in Europe. With the approval for the treatment of acne in January 2007, YAZ becomes the first and only oral contraceptive ever approved in the USA for three distinct indications.
