Priligy

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The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Priligy tablets. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the 60 mg tablet (over which there was disagreement) do outweigh its risks and that the marketing authorisation for Priligy granted in Sweden can be recognised in other Member States of the EU.

What is Priligy?

Priligy is a medicine used to treat premature ejaculation in men aged 18 to 64 years old.

Priligy is believed to increase the time it takes to ejaculate by increasing the amount of a neurotransmitter between the nerve cells.

The active substance, dapoxetine, is a selective serotonin re-uptake inhibitor (SSRI) and it works by preventing the neurotransmitter 5-hydroxytryptamine (also called serotonin) from being taken back up into nerve cells in the brain and spinal cord, thereby increasing the amount of serotonin between nerve cells.

Why was Priligy reviewed?

The company that markets Priligy in Sweden, Janssen-Cilag AB, submitted an application to market Priligy (30 mg and 60 mg tablets) through the mutual recognition procedure based on the initial authorisation granted by Sweden on 6 February 2009. The company wanted the authorisation to be recognised in Belgium, Bulgaria, Cyprus, Czech, Denmark, Estonia, Greece, France, Hungary, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Slovakia and the United Kingdom (the ‘concerned Member States’).

However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 24 February 2011.

The grounds for the referral were concerns over the benefit-risk balance of the 60 mg tablet by some Member States, who considered its additional benefit compared with the 30 mg tablet to be too modest when weighed against the increased risk of severe cases of syncope (fainting) seen in studies with the medicine.

What are the conclusions of the CHMP?

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Priligy 60 mg outweigh its risks, and that therefore the marketing authorisation for Priligy (30 mg and 60 mg) should be granted in all concerned Member States. The CHMP also concluded that the potential increased risk for syncope has been proven to be manageable. Patients should not start treatment with 60 mg tablets, and may only be switched to 60 mg if they have not responded sufficiently to the 30 mg tablets and have not experienced moderate or severe adverse reactions or symptoms suggestive of syncope.

The European Commission issued a decision on 20 January 2012.

Name Language First published Last updated
Questions and answers on the referral for Priligy BG = bălgarski 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy ES = español 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy CS = čeština 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy DA = dansk 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy DE = Deutsch 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy ET = eesti keel 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy EL = elliniká 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy EN = English 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy FR = français 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy IT = italiano 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy LV = latviešu valoda 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy LT = lietuvių kalba 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy HU = magyar 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy MT = Malti 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy NL = Nederlands 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy PL = polski 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy PT = português 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy RO = română 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy SK = slovenčina 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy SL = slovenščina 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy FI = suomi 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy SV = svenska 21/10/2011 28/03/2012

Key facts

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

dapoxetine

Associated names
Class
Reference numberEMEA/H/A-29/1294
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 date20/10/2011

All documents

Name Language First published Last updated
Priligy - Article 29 referral - Assessment report (English only) 28/03/2012  
Priligy - Article 29 referral - Annex I BG = bălgarski 28/03/2012  
Priligy - Article 29 referral - Annex I ES = español 28/03/2012  
Priligy - Article 29 referral - Annex I CS = čeština 28/03/2012  
Priligy - Article 29 referral - Annex I DA = dansk 28/03/2012  
Priligy - Article 29 referral - Annex I DE = Deutsch 28/03/2012  
Priligy - Article 29 referral - Annex I ET = eesti keel 28/03/2012  
Priligy - Article 29 referral - Annex I EL = elliniká 28/03/2012  
Priligy - Article 29 referral - Annex I EN = English 28/03/2012  
Priligy - Article 29 referral - Annex I FR = français 28/03/2012  
Priligy - Article 29 referral - Annex I IT = italiano 28/03/2012  
Priligy - Article 29 referral - Annex I LV = latviešu valoda 28/03/2012  
Priligy - Article 29 referral - Annex I LT = lietuvių kalba 28/03/2012  
Priligy - Article 29 referral - Annex I HU = magyar 28/03/2012  
Priligy - Article 29 referral - Annex I MT = Malti 28/03/2012  
Priligy - Article 29 referral - Annex I NL = Nederlands 28/03/2012  
Priligy - Article 29 referral - Annex I PL = polski 28/03/2012  
Priligy - Article 29 referral - Annex I PT = português 28/03/2012  
Priligy - Article 29 referral - Annex I RO = română 28/03/2012  
Priligy - Article 29 referral - Annex I SK = slovenčina 28/03/2012  
Priligy - Article 29 referral - Annex I SL = slovenščina 28/03/2012  
Priligy - Article 29 referral - Annex I FI = suomi 28/03/2012  
Priligy - Article 29 referral - Annex I SV = svenska 28/03/2012  
Priligy - Article 29 referral - Annex II BG = bălgarski 28/03/2012  
Priligy - Article 29 referral - Annex II ES = español 28/03/2012  
Priligy - Article 29 referral - Annex II CS = čeština 28/03/2012  
Priligy - Article 29 referral - Annex II DA = dansk 28/03/2012  
Priligy - Article 29 referral - Annex II DE = Deutsch 28/03/2012  
Priligy - Article 29 referral - Annex II ET = eesti keel 28/03/2012  
Priligy - Article 29 referral - Annex II EL = elliniká 28/03/2012  
Priligy - Article 29 referral - Annex II EN = English 28/03/2012  
Priligy - Article 29 referral - Annex II FR = français 28/03/2012  
Priligy - Article 29 referral - Annex II IT = italiano 28/03/2012  
Priligy - Article 29 referral - Annex II LV = latviešu valoda 28/03/2012  
Priligy - Article 29 referral - Annex II LT = lietuvių kalba 28/03/2012  
Priligy - Article 29 referral - Annex II HU = magyar 28/03/2012  
Priligy - Article 29 referral - Annex II MT = Malti 28/03/2012  
Priligy - Article 29 referral - Annex II NL = Nederlands 28/03/2012  
Priligy - Article 29 referral - Annex II PL = polski 28/03/2012  
Priligy - Article 29 referral - Annex II PT = português 28/03/2012  
Priligy - Article 29 referral - Annex II RO = română 28/03/2012  
Priligy - Article 29 referral - Annex II SK = slovenčina 28/03/2012  
Priligy - Article 29 referral - Annex II SL = slovenščina 28/03/2012  
Priligy - Article 29 referral - Annex II FI = suomi 28/03/2012  
Priligy - Article 29 referral - Annex II SV = svenska 28/03/2012  
Priligy - Article 29 referral - Annex III BG = bălgarski 28/03/2012  
Priligy - Article 29 referral - Annex III ES = español 28/03/2012  
Priligy - Article 29 referral - Annex III CS = čeština 28/03/2012  
Priligy - Article 29 referral - Annex III DA = dansk 28/03/2012  
Priligy - Article 29 referral - Annex III DE = Deutsch 28/03/2012  
Priligy - Article 29 referral - Annex III ET = eesti keel 28/03/2012  
Priligy - Article 29 referral - Annex III EL = elliniká 28/03/2012  
Priligy - Article 29 referral - Annex III EN = English 28/03/2012  
Priligy - Article 29 referral - Annex III FR = français 28/03/2012  
Priligy - Article 29 referral - Annex III IT = italiano 28/03/2012  
Priligy - Article 29 referral - Annex III LV = latviešu valoda 28/03/2012  
Priligy - Article 29 referral - Annex III LT = lietuvių kalba 28/03/2012  
Priligy - Article 29 referral - Annex III HU = magyar 28/03/2012  
Priligy - Article 29 referral - Annex III MT = Malti 28/03/2012  
Priligy - Article 29 referral - Annex III NL = Nederlands 28/03/2012  
Priligy - Article 29 referral - Annex III PL = polski 28/03/2012  
Priligy - Article 29 referral - Annex III PT = português 28/03/2012  
Priligy - Article 29 referral - Annex III RO = română 28/03/2012  
Priligy - Article 29 referral - Annex III SK = slovenčina 28/03/2012  
Priligy - Article 29 referral - Annex III SL = slovenščina 28/03/2012  
Priligy - Article 29 referral - Annex III FI = suomi 28/03/2012  
Priligy - Article 29 referral - Annex III SV = svenska 28/03/2012  
Questions and answers on the referral for Priligy BG = bălgarski 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy ES = español 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy CS = čeština 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy DA = dansk 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy DE = Deutsch 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy ET = eesti keel 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy EL = elliniká 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy EN = English 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy FR = français 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy IT = italiano 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy LV = latviešu valoda 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy LT = lietuvių kalba 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy HU = magyar 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy MT = Malti 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy NL = Nederlands 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy PL = polski 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy PT = português 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy RO = română 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy SK = slovenčina 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy SL = slovenščina 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy FI = suomi 21/10/2011 28/03/2012
Questions and answers on the referral for Priligy SV = svenska 21/10/2011 28/03/2012

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 Priligy