Tuesday, October 9, 2012

Bayer get European commission nod for its low dose combined oral contraceptive Flexyess

The European Commission has issued its go ahead for the approval of Bayer HealthCare’s new low-dose combined oral contraceptive Flexyess. Based on the European Commission’s positive decision, the Health Authorities of the EU Member States will grant national approvals in the coming weeks.

Flexyess (3 mg drospirenone/0.02 mg ethinylestradiol) will be the first low-dose combined oral contraceptive approved in the EU member states for a flexible extended regimen, offering women the option of ‘personal period planning’, meaning they can choose both the number and timing of their periods according to their needs (within the limits permitted by the approved dosing regimen). The new dosing regimen involves a daily intake for a minimum period of 24 days and up to a maximum period of 120 days. During day 25 to 120, women can schedule a 4-day tablet-free interval individually which triggers the period. This offers the option of flexibly reducing the number of periods to three per year.

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 expected to improve the adherence to tablet intake because it not only reminds women when to take their pill, but also advises them what to do if they have missed a pill and warns them if additional contraception is needed due to missed pills
Soruce Bayer Healthcare