On 19 April 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Yvidually and associated names. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Yvidually outweigh its risks, and the marketing authorisation can be granted in all EU Member States as well as Iceland and Norway.
- What is Yvidually?
Yvidually is a combined contraceptive pill. It contains two active substances, ethinylestradiol and drospirenone, which are derived from natural hormones produced in the ovaries: ethinylestradiol is derived from oestrogen and drospirenone is derived from progesterone. Yvidually works by changing the body’s hormonal balance to prevent ovulation, by altering the mucus in the cervix (neck of the womb) and by thinning the endometrium (the lining of the womb).
Yvidually is an ‘extended use’ oral contraceptive, which means that it can be taken daily for up to 120 days. The option of a tablet-free interval at any time during day 25 to 120 of the treatment cycle is also allowed.
Yvidually will be available as tablets in an automated tablet dispenser device with a reminder function for when the next pill has to be taken. This medicine will also be marketed as Flexyess.
- Why was Yvidually reviewed?
Bayer B.V. submitted Yvidually to the Netherlands' medicines regulatory agency for a decentralised procedure. This is a procedure where one Member State (the ‘reference Member State’, in this instance the Netherlands) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States’, in this instance Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmark, Estonia, Germany, Greece, Finland, France, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom).
However, the Member States were not able to reach an agreement and the Netherlands referred the matter to the CHMP for arbitration on 23 February 2012.
The grounds for the referral were concerns by France about the effectiveness of the proposed extended use of the medicine and the irregular bleeding episodes that might occur during the days of intake of the pill. France was also concerned that the tablet dispenser had not been used in the main clinical studies.
- What are the conclusions of the CHMP?
Based on evaluation of the available data and the scientific discussion within the Committee, the CHMP concluded that the contraceptive effectiveness during an extended use had been demonstrated. While different bleeding patterns had been reported during the days of pill intake, these bleeding episodes seemed to be well tolerated. The CHMP also noted that the concerns over the tablet dispenser had been adequately addressed, as an additional study provided by the company showed that women find the dispenser easy to use and that there were no problems with posology compliance. The CHMP therefore concluded that the benefits of Yvidually outweigh its risks, and therefore the marketing authorisation for Yvidually should be granted in all concerned Member States.
The European Commission issued a decision on 28 September 2012.
|International non-proprietary name (INN) or common name|
ethinylestradiol / drospirenone
|Type||Article 29(4) referrals|
This type of referral is triggered when there is a disagreement between Member States regarding a medicine being evaluated during a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.
|Status||European Commission final decision|
- Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
- Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
- List of the medicines affected by the referral (Annex I)
- Scientific conclusions of the Committee (Annex II)
The following two documents are sometimes available:
- Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies