- Procedure started
- Under evaluation
- CHMP opinion
- European Commission final decision
Genotropin, which contains the active ingredient somatropin, is a potent metabolic hormone of importance for the metabolism of lipids, carbohydrates and proteins. In children with inadequate endogenous growth hormone, somatropin stimulates linear growth and increases growth rate. In adults, as well as in children, somatropin maintains a normal body composition by increasing nitrogen retention and stimulation of skeletal muscle growth and by mobilisation of body fat. The first national Marketing Authorisation was granted in Denmark on 8 March 1988 and subsequently in all Member States.
On 22 November 2001, Germany and Sweden referred the matter to the EMEA under article 7(5) of Commission Regulation 541/95. Germany and Sweden considered that the data provided in the variations submitted by the Marketing Authorisation Holders to extend the indication to include children born small for gestational age (SGA) was not adequate to support the change requested as the limitation of the treatment period is likely to lead to high dose treatment and that a longer treatment time with a lower dose would be preferable, together with safety concerns regarding the increased risk at high doses for development of diabetes mellitus later in life.
The referral procedure started on 13 December 2001. The Rapporteur and Co-Rapporteur appointed were Dr. F. Lekkerkerker and Dr. P. Rossi, respectively. Written explanations were provided by the Marketing Authorisation Holders on 17 May 2002, 6 December 2002 and 25 February 2003.
Based on evaluation of the currently available data and the Rapporteurs' assessment reports, the CPMP considered that the benefit/risk profile of Genotropin in the indication “growth disturbance (current height SDS -2.5 and parental adjusted height SDS -1) in short children born small for gestational age (SGA), with a birth weight and/or length below –2 SD, who failed to show catch-up growth (HV SDS 0 during the last year) by 4 years of age or later” is favourable and therefore adopted on an opinion on 19 March 2003 recommending the variation to the Marketing Authorisations in accordance with the amended Summary of Product Characteristics.
The competent authorites of the Member States will continue to keep the product under regular review. A list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended Summary of Product Characteristics in Annex III.
The final opinion was converted into a Decision by the European Commission on 26 June 2003.
|International non-proprietary name (INN) or common name||
Article 6(12) referrals (prior to January 2010)
This type of referral was triggered for a medicine that had been authorised by mutual recognition or via the decentralised procedure when there was disagreement between Member States on a variation (type II). This referral has been replaced by Article 13 referrals.
European Commission final decision
|EC decision date||
Opinion following an Article 7(5) referal for Genotropin International Non-Proprietary Name (INN): Somatropin: Background information (PDF/301.1 KB)Adopted
First published: 26/06/2003
Last updated: 26/06/2003
- 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 havebeen recommended by the Committee
- Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies