Pharmaceuticals - Community Register

  

Community register of medicinal products for human use
AUTHORISED  

Product information
Invented name: INCRELEX   
Auth. number : EU/1/07/402
Active substance : Mecasermin
Orphan market exclusivity for "Treatment of primary insulin-like growth factor-1 deficiency due to molecular or genetic defects" (based on designation EU/3/06/373) started on 07/08/2007
   10 years of market exclusivity
   This orphan market exclusivity will expire on 07/08/2017
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H01 - Pituitary and hypothalamic hormones
Pharmacological subgroup: H01A - Anterior pituitary lobe hormones
Chemical subgroup: H01AC - Somatropin and analogues
Chemical substance: H01AC03 - Mecasermin
(See WHO ATC Index)
Indication: For the long-term treatment of growth failure in children and adolescents from 2 to 18 years with severe primary insulin-like growth factor-1 deficiency (Primary IGFD).Severe Primary IGFD is defined by:- height standard deviation score ≤ –3.0 and- basal IGF-1 levels below the 2.5th percentile for age and gender and- GH sufficiency.- Exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.
Marketing Authorisation Holder: Ipsen Pharma
65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page
Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
06/08/2007 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/704 (2007)3833 of 03/08/2007
07/08/2007 Centralised - Authorisation EMEA/H/C/704 (2007)3832 of 03/08/2007
23/11/2007 Centralised - Variation EMEA/H/C/704/IA/1
Updated with Decision(2008)3441 of 02/07/2008
04/07/2008 Centralised - Variation (2008)3441 of 02/07/2008
31/07/2008 Centralised - Variation EMEA/H/C/704/II/2 (2008)4166 of 29/07/2008
15/09/2008 Centralised - Variation EMEA/H/C/704/IA/4
Updated with Decision(2008)7426 of 20/11/2008
15/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/704/IA/5
24/11/2008 Centralised - Annual reassessment EMEA/H/C/704/S/3 (2008)7426 of 20/11/2008
17/03/2009 Centralised - Variation EMEA/H/C/704/IB/6
Updated with Decision(2009)5766 of 14/07/2009
17/03/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/704/IA/17
01/04/2009 Centralised - Variation EMEA/H/C/704/IA/8
Updated with Decision(2009)5766 of 14/07/2009
01/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/704/IA/9
16/07/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/704/T/10 (2009)5766 of 14/07/2009
26/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/704/II/11
01/04/2010 Centralised - Annual reassessment EMEA/H/C/704/S/12 (2010)2262 of 30/03/2010
02/08/2010 Centralised - Variation EMEA/H/C/704/II/13 (2010)5393 of 28/07/2010
03/02/2011 Centralised - Variation EMEA/H/C/704/II/14 (2011)689 of 01/02/2011
21/06/2011 Centralised - Annual reassessment EMEA/H/C/704/S/15 (2011)4406 of 16/06/2011
23/06/2011 Centralised - Variation EMEA/H/C/704/II/16/G (2011)4476 of 17/06/2011
07/08/2012 Centralised - Renewal EMEA/H/C/704/R/19, EMEA/H/C/704/S/18 (2012)5685 of 03/08/2012
04/09/2012 Centralised - Variation EMEA/H/C/704/II/20 (2012)6161 of 30/08/2012
24/04/2013 Centralised - Annual reassessment EMEA/H/C/704/S/21 (2013)2399 of 22/04/2013
07/11/2013 Centralised - Notification EMEA/H/C/704/N/22
Updated with Decision(2015)3164 of 05/05/2015
23/04/2014 Centralised - Notification EMEA/H/C/704/N/27
Updated with Decision(2015)3164 of 05/05/2015
25/04/2014 Centralised - Annual reassessment EMEA/H/C/704/S/24
15/08/2014 Centralised - Variation EMEA/H/C/704/IAin/30
Updated with Decision(2015)3164 of 05/05/2015
23/04/2015 Centralised - Variation EMEA/H/C/704/II/28
Updated with Decision(2016)2190 of 08/04/2016
07/05/2015 Centralised - Annual reassessment EMEA/H/C/704/S/32 (2015)3164 of 05/05/2015
29/05/2015 PSUSA - Modification EMEA/H/C/PSUSA/1942/201408 (2015)3668 of 27/05/2015
12/04/2016 Centralised - Annual reassessment EMEA/H/C/704/S/35 (2016)2190 of 08/04/2016
23/02/2017 Centralised - Annual reassessment EMEA/H/C/704/S/41
30/03/2017 Centralised - Variation EMEA/H/C/704/II/46/G
Updated with Decision(2017)3954 of 02/06/2017
07/06/2017 Centralised - 2-Monthly update EMEA/H/C/704/II/40 (2017)3954 of 02/06/2017
20/06/2017 Centralised - Renewal EMEA/H/C/704/R/42 (2017)4309 of 16/06/2017