Yvidually

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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.

Name Language First published Last updated
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) BG = bălgarski 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) ES = español 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) CS = čeština 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) DA = dansk 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) DE = Deutsch 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) ET = eesti keel 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) EL = elliniká 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) EN = English 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) FR = français 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) IT = italiano 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) LV = latviešu valoda 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) LT = lietuvių kalba 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) HU = magyar 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) MT = Malti 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) NL = Nederlands 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) PL = polski 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) PT = português 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) RO = română 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) SK = slovenčina 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) SL = slovenščina 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) FI = suomi 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) SV = svenska 2012-04-20 2012-01-03

Key facts

Approved nameYvidually
International non-proprietary name (INN) or common name

ethinylestradiol / drospirenone

Associated namesFlexyess
Class
Reference numberEMEA/H/A-29/1330
TypeArticle 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.

StatusEuropean Commission final decision
Opinion date19/04/2012

All documents

Name Language First published Last updated
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) BG = bălgarski 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) ES = español 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) CS = čeština 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) DA = dansk 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) DE = Deutsch 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) ET = eesti keel 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) EL = elliniká 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) EN = English 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) FR = français 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) IT = italiano 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) LV = latviešu valoda 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) LT = lietuvių kalba 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) HU = magyar 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) MT = Malti 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) NL = Nederlands 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) PL = polski 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) PT = português 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) RO = română 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) SK = slovenčina 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) SL = slovenščina 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) FI = suomi 2012-04-20 2012-01-03
Questions and answers on Yvidually and associated names (ethinylestradiol / drospirenone, 0.02 mg/3 mg tablets) SV = svenska 2012-04-20 2012-01-03
Yvidually Article 29(4) referral - Annex I BG = bălgarski 2013-01-03  
Yvidually Article 29(4) referral - Annex I ES = español 2013-01-03  
Yvidually Article 29(4) referral - Annex I CS = čeština 2013-01-03  
Yvidually Article 29(4) referral - Annex I DA = dansk 2013-01-03  
Yvidually Article 29(4) referral - Annex I DE = Deutsch 2013-01-03  
Yvidually Article 29(4) referral - Annex I ET = eesti keel 2013-01-03  
Yvidually Article 29(4) referral - Annex I EL = elliniká 2013-01-03  
Yvidually Article 29(4) referral - Annex I EN = English 2013-01-03  
Yvidually Article 29(4) referral - Annex I FR = français 2013-01-03  
Yvidually Article 29(4) referral - Annex I IT = italiano 2013-01-03  
Yvidually Article 29(4) referral - Annex I LV = latviešu valoda 2013-01-03  
Yvidually Article 29(4) referral - Annex I LT = lietuvių kalba 2013-01-03  
Yvidually Article 29(4) referral - Annex I HU = magyar 2013-01-03  
Yvidually Article 29(4) referral - Annex I MT = Malti 2013-01-03  
Yvidually Article 29(4) referral - Annex I NL = Nederlands 2013-01-03  
Yvidually Article 29(4) referral - Annex I PL = polski 2013-01-03  
Yvidually Article 29(4) referral - Annex I PT = português 2013-01-03  
Yvidually Article 29(4) referral - Annex I RO = română 2013-01-03  
Yvidually Article 29(4) referral - Annex I SK = slovenčina 2013-01-03  
Yvidually Article 29(4) referral - Annex I SL = slovenščina 2013-01-03  
Yvidually Article 29(4) referral - Annex I FI = suomi 2013-01-03  
Yvidually Article 29(4) referral - Annex I SV = svenska 2013-01-03  
Yvidually Article 29(4) referral - Annex II BG = bălgarski 2013-01-03  
Yvidually Article 29(4) referral - Annex II ES = español 2013-01-03  
Yvidually Article 29(4) referral - Annex II CS = čeština 2013-01-03  
Yvidually Article 29(4) referral - Annex II DA = dansk 2013-01-03  
Yvidually Article 29(4) referral - Annex II DE = Deutsch 2013-01-03  
Yvidually Article 29(4) referral - Annex II ET = eesti keel 2013-01-03  
Yvidually Article 29(4) referral - Annex II EL = elliniká 2013-01-03  
Yvidually Article 29(4) referral - Annex II EN = English 2013-01-03  
Yvidually Article 29(4) referral - Annex II FR = français 2013-01-03  
Yvidually Article 29(4) referral - Annex II IT = italiano 2013-01-03  
Yvidually Article 29(4) referral - Annex II LV = latviešu valoda 2013-01-03  
Yvidually Article 29(4) referral - Annex II HU = magyar 2013-01-03  
Yvidually Article 29(4) referral - Annex II NL = Nederlands 2013-01-03  
Yvidually Article 29(4) referral - Annex II PL = polski 2013-01-03  
Yvidually Article 29(4) referral - Annex II PT = português 2013-01-03  
Yvidually Article 29(4) referral - Annex II RO = română 2013-01-03  
Yvidually Article 29(4) referral - Annex II SK = slovenčina 2013-01-03  
Yvidually Article 29(4) referral - Annex II SL = slovenščina 2013-01-03  
Yvidually Article 29(4) referral - Annex II FI = suomi 2013-01-03  
Yvidually Article 29(4) referral - Annex III BG = bălgarski 2013-01-03  
Yvidually Article 29(4) referral - Annex III ES = español 2013-01-03  
Yvidually Article 29(4) referral - Annex III CS = čeština 2013-01-03  
Yvidually Article 29(4) referral - Annex III DA = dansk 2013-01-03  
Yvidually Article 29(4) referral - Annex III DE = Deutsch 2013-01-03  
Yvidually Article 29(4) referral - Annex III ET = eesti keel 2013-01-03  
Yvidually Article 29(4) referral - Annex III EL = elliniká 2013-01-03  
Yvidually Article 29(4) referral - Annex III EN = English 2013-01-03  
Yvidually Article 29(4) referral - Annex III FR = français 2013-01-03  
Yvidually Article 29(4) referral - Annex III IT = italiano 2013-01-03  
Yvidually Article 29(4) referral - Annex III LV = latviešu valoda 2013-01-03  
Yvidually Article 29(4) referral - Annex III LT = lietuvių kalba 2013-01-03  
Yvidually Article 29(4) referral - Annex III HU = magyar 2013-01-03  
Yvidually Article 29(4) referral - Annex III MT = Malti 2013-01-03  
Yvidually Article 29(4) referral - Annex III NL = Nederlands 2013-01-03  
Yvidually Article 29(4) referral - Annex III PL = polski 2013-01-03  
Yvidually Article 29(4) referral - Annex III PT = português 2013-01-03  
Yvidually Article 29(4) referral - Annex III RO = română 2013-01-03  
Yvidually Article 29(4) referral - Annex III SK = slovenčina 2013-01-03  
Yvidually Article 29(4) referral - Annex III FI = suomi 2013-01-03  
Yvidually Article 29(4) referral - Annex III SV = svenska 2013-01-03  
Yvidually Article 29(4) referral - Annex IV BG = bălgarski 2013-01-03  
Yvidually Article 29(4) referral - Annex IV ES = español 2013-01-03  
Yvidually Article 29(4) referral - Annex IV CS = čeština 2013-01-03  
Yvidually Article 29(4) referral - Annex IV DA = dansk 2013-01-03  
Yvidually Article 29(4) referral - Annex IV DE = Deutsch 2013-01-03  
Yvidually Article 29(4) referral - Annex IV ET = eesti keel 2013-01-03  
Yvidually Article 29(4) referral - Annex IV EL = elliniká 2013-01-03  
Yvidually Article 29(4) referral - Annex IV EN = English 2013-01-03  
Yvidually Article 29(4) referral - Annex IV FR = français 2013-01-03  
Yvidually Article 29(4) referral - Annex IV IT = italiano 2013-01-03  
Yvidually Article 29(4) referral - Annex IV LV = latviešu valoda 2013-01-03  
Yvidually Article 29(4) referral - Annex IV LT = lietuvių kalba 2013-01-03  
Yvidually Article 29(4) referral - Annex IV HU = magyar 2013-01-03  
Yvidually Article 29(4) referral - Annex IV MT = Malti 2013-01-03  
Yvidually Article 29(4) referral - Annex IV NL = Nederlands 2013-01-03  
Yvidually Article 29(4) referral - Annex IV PL = polski 2013-01-03  
Yvidually Article 29(4) referral - Annex IV PT = português 2013-01-03  
Yvidually Article 29(4) referral - Annex IV RO = română 2013-01-03  
Yvidually Article 29(4) referral - Annex IV SK = slovenčina 2013-01-03  
Yvidually Article 29(4) referral - Annex IV SL = slovenščina 2013-01-03  
Yvidually Article 29(4) referral - Annex IV FI = suomi 2013-01-03  
Yvidually Article 29(4) referral - Annex IV SV = svenska 2013-01-03  
Yvidually Article 29(4) referral - Assessment report (English only) 2013-01-03  

Document description

  • 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

Current status:
European Commission final decision

More information on Yvidually