Norditropin

  • Email
  • Help

The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names. The Agency’s Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a requested change to the marketing authorisation for these medicines to include a new indication for use in children with Prader-Willi syndrome. The Committee concluded that the change to the marketing authorisation cannot be granted.

What is Norditropin?

Norditropin is a medicine that contains somatropin, which is a copy of naturally occurring human growth hormone. Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.

Norditropin is used as replacement therapy in children and adults who have a growth hormone deficiency. It is also used to correct short height in girls who have the genetic disease called Turner syndrome, in children who have long-standing kidney problems, and in children born small for their gestational age and who have not caught up by the age of four.

The somatropin in Norditropin is produced by a method known as ‘recombinant DNA technology’: it is made by an organism that has received a gene (DNA), which makes the organism able to produce it.

Norditropin is marketed in the European Union Member States under the names Norditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx and associated names. The company that makes the medicine is NovoNordisk.

Why was Norditropin reviewed?

Norditropin is authorised under a mutual recognition procedure based on an initial authorisation granted by Denmark. In May 2010, the company applied for an additional indication in Denmark and in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom1. The new indication was for the use of Norditropin in children with Prader-Willi syndrome, a rare genetic disease that affects children’s growth and development. Although somatropin medicines are already approved in EU Member States for use in Prader-Willi syndrome, the Member States were unable to reach agreement on whether to accept this indication for Norditropin. On 20 April 2011, Denmark referred the matter to the CHMP for arbitration. 

The grounds for the referral were the concerns of some Member States that the data on Norditropin submitted in the application were not sufficient to demonstrate its effectiveness in Prader-Willi syndrome. The Member States cited methodological weaknesses in the study presented, the wide range of doses used and insufficient data (e.g. missing data on body composition measurements).

1 In May 2011 the marketing authorisations of the concerned products were withdrawn in Estonia, and in June 2011 the marketing authorisations of the concerned products were withdrawn in Latvia.

What are the conclusions of the CHMP?

The Committee looked at the study presented by the company to support the new indication.

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that the data were insufficient and that the study presented, which was an observational study, did not meet required methodological standards. The CHMP therefore recommended that the new indication for Norditropin and associated names should not be granted in Denmark or in the concerned Member States.

The European Commission issued a decision on 6 March 2012.

Name Language First published Last updated
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) BG = bălgarski 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) ES = español 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) CS = čeština 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) DA = dansk 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) DE = Deutsch 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) ET = eesti keel 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) EL = elliniká 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) EN = English 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) FR = français 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) IT = italiano 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) LV = latviešu valoda 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) LT = lietuvių kalba 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) HU = magyar 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) MT = Malti 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) NL = Nederlands 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) PL = polski 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) PT = português 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) RO = română 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) SK = slovenčina 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) SL = slovenščina 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) FI = suomi 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) SV = svenska 2011-12-16 2012-04-19

Key facts

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

somatropin

Associated namesNorditropin FlexPro, Norditropin NordiFlex, Norditropin SimpleXx
Class
Reference numberEMEA/H/A-13/1304
TypeArticle 13 referrals

This type of referral is triggered for a medicine that has been authorised by mutual recognition or via the decentralised procedure when there is disagreement between Member States on a variation (type II).

StatusEuropean Commission final decision
Opinion date15/12/2011

All documents

Name Language First published Last updated
Norditropin - Article 13 referral - Assessment Report (English only) 2012-04-19  
Norditropin - Article 13 referral - Annex I BG = bălgarski 2012-04-19  
Norditropin - Article 13 referral - Annex I ES = español 2012-04-19  
Norditropin - Article 13 referral - Annex I CS = čeština 2012-04-19  
Norditropin - Article 13 referral - Annex I DA = dansk 2012-04-19  
Norditropin - Article 13 referral - Annex I DE = Deutsch 2012-04-19  
Norditropin - Article 13 referral - Annex I ET = eesti keel 2012-04-19  
Norditropin - Article 13 referral - Annex I EL = elliniká 2012-04-19  
Norditropin - Article 13 referral - Annex I EN = English 2012-04-19  
Norditropin - Article 13 referral - Annex I FR = français 2012-04-19  
Norditropin - Article 13 referral - Annex I IT = italiano 2012-04-19  
Norditropin - Article 13 referral - Annex I LV = latviešu valoda 2012-04-19  
Norditropin - Article 13 referral - Annex I LT = lietuvių kalba 2012-04-19  
Norditropin - Article 13 referral - Annex I HU = magyar 2012-04-19  
Norditropin - Article 13 referral - Annex I MT = Malti 2012-04-19  
Norditropin - Article 13 referral - Annex I NL = Nederlands 2012-04-19  
Norditropin - Article 13 referral - Annex I PL = polski 2012-04-19  
Norditropin - Article 13 referral - Annex I PT = português 2012-04-19  
Norditropin - Article 13 referral - Annex I RO = română 2012-04-19  
Norditropin - Article 13 referral - Annex I SK = slovenčina 2012-04-19  
Norditropin - Article 13 referral - Annex I SL = slovenščina 2012-04-19  
Norditropin - Article 13 referral - Annex I FI = suomi 2012-04-19  
Norditropin - Article 13 referral - Annex I SV = svenska 2012-04-19  
Norditropin - Article 13 referral - Annex II BG = bălgarski 2012-04-19  
Norditropin - Article 13 referral - Annex II ES = español 2012-04-19  
Norditropin - Article 13 referral - Annex II CS = čeština 2012-04-19  
Norditropin - Article 13 referral - Annex II DA = dansk 2012-04-19  
Norditropin - Article 13 referral - Annex II DE = Deutsch 2012-04-19  
Norditropin - Article 13 referral - Annex II ET = eesti keel 2012-04-19  
Norditropin - Article 13 referral - Annex II EL = elliniká 2012-04-19  
Norditropin - Article 13 referral - Annex II EN = English 2012-04-19  
Norditropin - Article 13 referral - Annex II FR = français 2012-04-19  
Norditropin - Article 13 referral - Annex II IT = italiano 2012-04-19  
Norditropin - Article 13 referral - Annex II LV = latviešu valoda 2012-04-19  
Norditropin - Article 13 referral - Annex II LT = lietuvių kalba 2012-04-19  
Norditropin - Article 13 referral - Annex II HU = magyar 2012-04-19  
Norditropin - Article 13 referral - Annex II MT = Malti 2012-04-19  
Norditropin - Article 13 referral - Annex II NL = Nederlands 2012-04-19  
Norditropin - Article 13 referral - Annex II PL = polski 2012-04-19  
Norditropin - Article 13 referral - Annex II PT = português 2012-04-19  
Norditropin - Article 13 referral - Annex II RO = română 2012-04-19  
Norditropin - Article 13 referral - Annex II SK = slovenčina 2012-04-19  
Norditropin - Article 13 referral - Annex II SL = slovenščina 2012-04-19  
Norditropin - Article 13 referral - Annex II FI = suomi 2012-04-19  
Norditropin - Article 13 referral - Annex II SV = svenska 2012-04-19  
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) BG = bălgarski 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) ES = español 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) CS = čeština 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) DA = dansk 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) DE = Deutsch 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) ET = eesti keel 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) EL = elliniká 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) EN = English 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) FR = français 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) IT = italiano 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) LV = latviešu valoda 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) LT = lietuvių kalba 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) HU = magyar 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) MT = Malti 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) NL = Nederlands 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) PL = polski 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) PT = português 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) RO = română 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) SK = slovenčina 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) SL = slovenščina 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) FI = suomi 2011-12-16 2012-04-19
Questions and answers on Norditropin and associated names (somatropin, 5 mg, 10 mg and 15 mg/1.5 ml solution for injection) SV = svenska 2011-12-16 2012-04-19

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