Yvidually - referral

Current status

European Commission final decision

Overview

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.

Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets)

Adopted Reference Number: EMA/265750/2012 Rev.1 Summary:

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.

Key facts

About this medicine

• Approved name:
  Yvidually
• International non-proprietary name (INN) or common name:
  • ethinylestradiol
  • drospirenone
• Associated names:
  Flexyess

About this procedure

• Current status:
  European Commission final decision
• Reference number:
  EMEA/H/A-29/1330
• Type:
  Article 29(4) referrals

  This type of referral is triggered when there is a disagreement between Member States regarding a marketing authorisation application being evaluated in a mutual-recognition or decentralised procedure, on the grounds of a potential serious risk to public health.

Key dates and outcomes

• CHMP opinion date:
  19/04/2012
• EC decision date:
  28/09/2012

All documents

European Commission final decision

Yvidually Article 29(4) referral - Annex I

Yvidually Article 29(4) referral - Annex II

Yvidually Article 29(4) referral - Annex III

Yvidually Article 29(4) referral - Annex IV

Yvidually Article 29(4) referral - Assessment report

Adopted Reference Number: EMA/552336/2012

Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets)

Adopted Reference Number: EMA/265750/2012 Rev.1 Summary:

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.

Description of documents published

Please note that some of the listed documents apply only to certain procedures.

• Overview - lay-language summary of the stage of the procedure
• Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
• Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
• List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
• Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
• List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
• List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
• Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
• Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
• Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
• Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
• Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
• Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
• Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
• Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

Note that older documents may have different titles.