- 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) referral 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
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.