Levothyroxine Alapis

  • Email
  • Help

On 18 October 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 Levothyroxine Alapis. The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Levothyroxine Alapis do not outweigh its risks, and the marketing authorisation cannot be granted in the Netherlands or in the following EU Member States: Belgium, Bulgaria, Cyprus, Germany, Greece, Malta, Portugal, Romania and United Kingdom.

What is Levothyroxine Alapis?

Levothryoxine Alapis is a medicine that contains the active substance levothyroxine sodium. It was to be available as oral drops (100 microgram/ml). The active substance in Levothyroxine Alapis, levothyroxine sodium, is a synthetic form of the hormone thyroxine. Thyroxine is normally produced in the body by the thyroid gland in the neck. It controls many body functions, mainly to do with growth and energy. Levothyroxine Alapis was intended to be used to treat:

  • conditions in which the thyroid gland is underactive (hypothyroidism, including diffuse non-toxic goitre) and so does not make enough thyroxine for the body’s needs;
  • a condition known as Hashimoto’s thyroiditis, in which the immune system (the body’s natural defences) attacks the thyroid causing it to swell and preventing it from working properly;
  • thyroid cancer.

 

Why was Levothyroxine Alapis reviewed?

Alapis S.A. submitted an application for Levothyroxine Alapis to the Dutch 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 Belgium, Bulgaria, Cyprus, Germany, Greece, Malta, Portugal, Romania and United Kingdom).

However, the Member States were not able to reach an agreement and the Dutch agency referred the matter to the CHMP for arbitration on 26 January 2012.

The grounds for the referral were concerns raised by the UK related to the dropper insert as a proposed administration device, due to the large number of drops that may be required and concerns about its accuracy in delivering the required dose. This could potentially lead to medication errors and pose a risk to public health. In addition there were concerns over the safety of the combined long-term use of the ingredients ethanol and propylene glycol at the proposed concentrations, particularly in children.

What are the conclusions of the CHMP?

Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that there was a risk that the dropper used for delivery might deliver variable doses, and that large numbers of drops might be hard to count. Since the solution is highly concentrated and the active substance highly potent, there was an unacceptable risk of serious medication errors. In addition, there remained concern over the safety of the long-term use of the ingredients ethanol and propylene glycol in children, and some groups of adults such as those with alcoholism. Therefore the CHMP concluded that the benefits of Levothyroxine Alapis do not outweigh its risks, and that the marketing authorisation should not be granted in the concerned Member States.

The European Commission issued a decision on 14 January 2013.

Name Language First published Last updated
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) BG = bălgarski 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) ES = español 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) CS = čeština 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) DA = dansk 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) DE = Deutsch 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) ET = eesti keel 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) EL = elliniká 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) EN = English 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) FR = français 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) IT = italiano 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) LV = latviešu valoda 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) LT = lietuvių kalba 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) HU = magyar 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) MT = Malti 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) NL = Nederlands 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) PL = polski 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) PT = português 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) RO = română 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) SK = slovenčina 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) SL = slovenščina 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) FI = suomi 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) SV = svenska 2012-10-19 2013-02-15

Key facts

Approved nameLevothyroxine Alapis
International non-proprietary name (INN) or common name

 levothyroxine sodium

Associated names-
Class-
Reference numberEMEA/H/A-29/1328
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.

StatusOpinion provided by Committee for Medicinal Products for Human Use
Opinion date18/10/2012

All documents

Name Language First published Last updated
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) BG = bălgarski 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) ES = español 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) CS = čeština 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) DA = dansk 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) DE = Deutsch 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) ET = eesti keel 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) EL = elliniká 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) EN = English 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) FR = français 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) IT = italiano 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) LV = latviešu valoda 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) LT = lietuvių kalba 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) HU = magyar 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) MT = Malti 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) NL = Nederlands 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) PL = polski 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) PT = português 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) RO = română 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) SK = slovenčina 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) SL = slovenščina 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) FI = suomi 2012-10-19 2013-02-15
Questions and answers on Levothyroxine Alapis and associated names (levothyroxine sodium, oral drops, 100 microgram/ml) SV = svenska 2012-10-19 2013-02-15
Levothyroxine Alapis- Article 29 referral - Assessment report (English only) 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I BG = bălgarski 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I ES = español 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I CS = čeština 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I DA = dansk 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I DE = Deutsch 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I ET = eesti keel 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I EL = elliniká 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I EN = English 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I FR = français 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I IT = italiano 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I LV = latviešu valoda 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I LT = lietuvių kalba 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I HU = magyar 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I MT = Malti 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I NL = Nederlands 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I PL = polski 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I PT = português 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I RO = română 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I SK = slovenčina 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I SL = slovenščina 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I FI = suomi 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex I SV = svenska 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II BG = bălgarski 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II ES = español 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II CS = čeština 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II DA = dansk 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II DE = Deutsch 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II ET = eesti keel 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II EL = elliniká 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II EN = English 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II FR = français 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II IT = italiano 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II LV = latviešu valoda 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II LT = lietuvių kalba 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II HU = magyar 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II MT = Malti 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II NL = Nederlands 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II PL = polski 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II PT = português 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II RO = română 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II SK = slovenčina 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II SL = slovenščina 2013-02-15  
Levothyroxine Alapis - Article 29(4) referral - Annex II FI = suomi 2013-02-15  

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:
Opinion provided by Committee for Medicinal Products for Human Use

More information on Levothyroxine Alapis