Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Somavert   
Auth. number : EU/1/02/240
INN : Pegvisomant
Orphan status based on designation EU/3/01/023 added on 15/11/2002
Orphan status based on designation EU/3/01/023 removed or expired on 15/11/2012
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: H01AX - Other anterior pituitary lobe hormones and analogues
Chemical substance: H01AX01 - Pegvisomant
(See WHO ATC Index)
Indication: Treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiation therapy
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

  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
15/11/2002 Centralised - Authorisation EMEA/H/C/409 (2002)4515 of 13/11/2002
20/08/2003 Centralised - Variation EMEA/H/C/409/II/1 (2003)3084 of 18/08/2003
18/09/2003 Centralised - Variation EMEA/H/C/409/I/2 (2003)3339 of 16/09/2003
22/10/2003 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/409/T/3 (2003)3964 of 20/10/2003
28/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IA/5
06/08/2004 Centralised - Variation EMEA/H/C/409/II/4 (2004)3094 of 04/08/2004
18/01/2005 Centralised - Notification EMEA/H/C/409/N/6
Updated with Decision(2005)3535 of 13/09/2005
31/01/2005 Centralised - Variation EMEA/H/C/409/IB/7
Updated with Decision(2005)3535 of 13/09/2005
21/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/8
14/09/2005 Centralised - Variation (2005)3535 of 13/09/2005
14/11/2005 Centralised - Notification EMEA/H/C/409/N/11
Updated with Decision(2007)4438 of 20/09/2007
23/11/2005 Centralised - Variation EMEA/H/C/409/II/9 (2005)4510 of 15/11/2005
24/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/10
20/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/I/12
31/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/14, 16
07/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IB/19
28/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/15, 17
24/09/2007 Centralised - Renewal EMEA/H/C/409/R/20 (2007)4438 of 20/09/2007
27/12/2007 Centralised - Variation EMEA/H/C/409/II/21 (2007)6869 of 21/12/2007
31/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/24
05/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/22, 23
21/05/2008 Centralised - Variation EMEA/H/C/409/IA/26
Updated with Decision(2008)8730 of 16/12/2008
03/06/2008 Centralised - Variation EMEA/H/C/409/IB/25
Updated with Decision(2008)8730 of 16/12/2008
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/27, 28
18/12/2008 Centralised - Variation (2008)8730 of 16/12/2008
07/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/29
08/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/31
07/04/2009 Centralised - Notification EMEA/H/C/409/N/30
Updated with Decision(2009)9337 of 20/11/2009
12/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/34
05/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/33
27/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/37
24/11/2009 Centralised - Variation EMEA/H/C/409/II/35 (2009)9337 of 20/11/2009
07/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/38
27/01/2010 Centralised - Variation EMEA/H/C/409/II/36 (2010)517 of 25/01/2010
02/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/II/39
03/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IB/40
14/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IB/42
14/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IB/41
27/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IA/44
27/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IA/43
26/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IA/46
14/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IB/45
18/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IA/48
18/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IA/49
30/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/409/IA/50
21/04/2011 Centralised - Variation EMEA/H/C/409/II/47/G (2011)2861 of 18/04/2011
21/12/2011 Centralised - Variation EMEA/H/C/409/II/51 (2011)9944 of 19/12/2011
21/06/2012 Centralised - Variation EMEA/H/C/409/IA/58/G
Updated with Decision(2012)6387 of 10/09/2012
12/09/2012 Centralised - Variation (2012)6387 of 10/09/2012
15/11/2012 Centralised - (orphan status)
03/09/2013 Centralised - Notification EMEA/H/C/409/N/65
20/02/2014 Centralised - Variation EMEA/H/C/409/II/68
30/10/2014 Centralised - Variation EMEA/H/C/409/IA/74/G