European Commission approves Bayer HealthCare's oral contraceptive Flexyess
The European Commission has granted approval to Bayer HealthCare’s new low-dose combined oral contraceptive Flexyness. As per the decision of the European Commission, the health authorities of EU member states will give national approvals in the coming weeks.
Flexyess (3mg drosprirenone/0.02mg ethinylestradiol) will be the first low-dose combined combined oral contraceptive approved in the EU member states for a flexible extended regimen, offering women of personal period planning. This means they can choose both the number and timings of their periods as per their needs.
The dosage regimen also involves a daily intake for 24 days and up to a maximum period of 120 days. Dr. Flemming Ornskoy, Chief Marketing Officer at Bayer Health said, “Once Flexyess is launched, women will have the convenience and flexibility to influence the timing of their periods according to their individual needs.”
The oral contraceptive Flexyess comes with Clyktm, an innovative digital tablet dispenser that is designed to support women with the new regimen and remind them when to take their pill.
The tablet dispenser is likely to improve the adherence to tablet intake as it reminds women when to take their pill. It also advises them of what to do if they have missed a pill and warns them if additional contraception is required due to the missed pills.
Flexyess provides reliable contraception when taken as directed. It has proved effective in preventing pregnancy in clinical studies involving more than 2,500 women aged 18-45 years.
The first launches of the product in the EU are expected in the second half of 2013. The name of the combined oral contraceptive can differ from country to country.
Bayer HealthCare is a subsidiary of Bayer AG. It is also the world’s leading and innovative companies in the medical products and healthcare industry. The company also plays a vital part in improving the health of people and animals.