Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: NutropinAq   
Auth. number : EU/1/00/164
INN : Somatropin
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: H01AC01 - Somatropin
(See WHO ATC Index)
Indication: Paediatric population

- Long-term treatment of children with growth failure due to inadequate endogenous growth hormone secretion.
- Long-term treatment of girls from 2 years old with growth failure associated with Turner syndrome.
- Treatment of prepubertal children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation.

Adult population

- Replacement of endogenous growth hormone in adults with growth hormone deficiency of either childhood or adult-onset etiology. Growth hormone deficiency should be confirmed appropriately prior to treatment. 
 In adults with growth hormone deficiency the diagnosis should be established depending on the etiology:
 Adult-onset: The patient must have growth hormone deficiency as a result of hypothalamic or pituitary disease, and at least one other hormone deficiency diagnosed (except for prolactin). Test for growth hormone deficiency should not be performed until adequate replacement therapy for other hormone deficiencies have been instituted.
 Childhood-onset: Patients who have had growth hormone deficiency as a child should be retested to confirm growth hormone deficiency in adulthood before replacement therapy with NutropinAq is started.
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
20/02/2001 Centralised - Authorisation EMEA/H/C/315 (2001)242 of 16/02/2001
23/12/2002 Centralised - Variation EMEA/H/C/315/N/1 (2002)5434 of 18/12/2002
26/02/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/315/T/2 (2003)681 of 24/02/2003
23/07/2003 Centralised - Variation EMEA/H/C/315/I/3 (2003)2716 of 18/07/2003
20/08/2003 Centralised - Variation EMEA/H/C/315/I/4
30/09/2003 Centralised - Variation EMEA/H/C/315/II/5
23/03/2004 Centralised - Variation EMEA/H/C/315/II/6 (2004)1052 of 19/03/2004
23/08/2004 Centralised - Variation EMEA/H/C/315/N/7
Updated with Decision(2004)4847 of 06/12/2004
02/09/2004 Centralised - Variation EMEA/H/C/315/IA/8
Updated with Decision(2004)4847 of 06/12/2004
08/12/2004 Centralised - Variation EMEA/H/C/315/II/9 (2004)4847 of 06/12/2004
21/12/2004 Centralised - Variation EMEA/H/C/315/IB/17
25/02/2005 Centralised - Variation EMEA/H/C/315/II/11, 13
14/03/2005 Centralised - Variation EMEA/H/C/315/N/18
Updated with Decision(2006)976 of 21/03/2006
21/04/2005 Centralised - Variation EMEA/H/C/315/II/1, 12, 14
02/05/2005 Centralised - Variation EMEA/H/C/315/II/12
02/05/2005 Centralised - Variation EMEA/H/C/315/II/14
02/05/2005 Centralised - Variation EMEA/H/C/315/II/10
17/10/2005 Centralised - Variation EMEA/H/C/315/N/20
Updated with Decision(2006)976 of 21/03/2006
28/10/2005 Centralised - Variation EMEA/H/C/315/IA/22
23/03/2006 Centralised - Renewal EMEA/H/C/315/R/21 (2006)976 of 21/03/2006
05/05/2006 Centralised - Variation EMEA/H/C/315/II/23
27/09/2006 Centralised - Variation EMEA/H/C/315/II/26
01/11/2006 Centralised - Variation EMEA/H/C/315/II/25 (2006)5333 of 30/10/2006
20/03/2007 Centralised - Variation EMEA/H/C/315/IA/27
05/05/2008 Centralised - Variation EMEA/H/C/315/N/28
Updated with Decision(2009)6189 of 29/07/2009
21/01/2009 Centralised - Variation EMEA/H/C/315/N/29
Updated with Decision(2009)6189 of 29/07/2009
31/07/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/315/T/30 (2009)6189 of 29/07/2009
21/12/2009 Centralised - Variation EMEA/H/C/315/N/31
Updated with Decision(2011)464 of 24/01/2011
20/05/2010 Centralised - Variation EMEA/H/C/315/IA/35
21/05/2010 Centralised - Variation EMEA/H/C/315/IA/36
01/06/2010 Centralised - Variation EMEA/H/C/315/IB/34
05/07/2010 Centralised - Variation EMEA/H/C/315/II/33
20/07/2010 Centralised - Variation EMEA/H/C/315/IB/37
20/07/2010 Centralised - Variation EMEA/H/C/315/IB/37
09/10/2010 Centralised - Variation EMEA/H/C/315/II/32
27/01/2011 Centralised - Variation EMEA/H/C/315/II/39 (2011)464 of 24/01/2011
19/04/2011 Centralised - Variation EMEA/H/C/315/II/38 (2011)2797 of 14/04/2011
01/06/2011 Centralised - Variation EMEA/H/C/315/N/41
Updated with Decision(2012)1502 of 02/03/2012
06/03/2012 Referral EMEA/H/C/315/A-20/40 (2012)1502 of 02/03/2012
25/04/2013 Centralised - Variation EMEA/H/C/315/II/48
Updated with Decision(2014)3096 of 06/05/2014
09/05/2014 Centralised - Variation (2014)3096 of 06/05/2014