Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cetrotide   
Auth. number : EU/1/99/100
INN : Cetrorelix (as acetate)
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H05 - Calcium homeostasis
Pharmacological subgroup: H05B - Anti-parathyroid hormones
Chemical subgroup: H05BA - Calcitonin preparations
Chemical substance: H05BA01 - Calcitonin (salmon synthetic)
(See WHO ATC Index)
Indication: Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.In clinical trials Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.
Marketing Authorisation Holder: Serono Europe Limited
56, Marsh Wall, London E14 9TP, 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 continues to be 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
15/04/1999 Centralised - Authorisation EMEA/H/C/233 (1999)939 of 13/04/1999
27/09/1999 Centralised - Variation EMEA/H/C/233/N/1 (1999)3012 of 16/09/1999
05/06/2000 Centralised - Variation EMEA/H/C/233/N/3 (2000)1410 of 29/05/2000
20/02/2001 Centralised - Variation EMEA/H/C/233/I/5
22/03/2001 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/233/T/6 (2001)767 of 20/03/2001
02/05/2001 Centralised - Variation EMEA/H/C/233/II/8
25/09/2001 Centralised - Variation EMEA/H/C/233/II/7 (2001)2734 of 20/09/2001
23/04/2002 Centralised - Variation EMEA/H/C/233/I/10 (2002)1572 of 19/04/2002
23/04/2002 Centralised - Variation EMEA/H/C/233/I/9 (2002)1571 of 19/04/2002
17/01/2003 Centralised - Variation EMEA/H/C/233/II/11 (2003)318 of 15/01/2003
10/03/2003 Centralised - Variation EMEA/H/C/233/N/12 (2003)772 of 06/03/2003
29/09/2003 Centralised - Variation EMEA/H/C/233/II/13
19/11/2003 Centralised - Variation EMEA/H/C/233/I/14
20/08/2004 Centralised - Renewal EMEA/H/C/233/R/15 (2004)3246 of 17/08/2004
22/09/2004 Centralised - Variation EMEA/H/C/233/IB/16
22/09/2004 Centralised - Variation EMEA/H/C/233/IB/17
24/05/2005 Centralised - Variation EMEA/H/C/233/N/18
Updated with Decision(2006)5013 of 17/10/2006
24/05/2006 Centralised - Variation EMEA/H/C/233/IA/19
Updated with Decision(2006)5013 of 17/10/2006
19/10/2006 Centralised - Variation EMEA/H/C/233/II/20 (2006)5013 of 17/10/2006
07/02/2007 Centralised - Variation EMEA/H/C/233/IB/21
26/06/2007 Centralised - Variation EMEA/H/C/233/N/22
Updated with Decision(2008)4950 of 02/09/2008
21/01/2008 Centralised - Variation EMEA/H/C/233/IA/24
Updated with Decision(2008)4950 of 02/09/2008
22/01/2008 Centralised - Variation EMEA/H/C/233/IB/25
02/06/2008 Centralised - Variation EMEA/H/C/233/IA/27
04/08/2008 Centralised - Variation EMEA/H/C/233/II/26
05/09/2008 Centralised - Variation (2008)4950 of 02/09/2008
27/03/2009 Centralised - Renewal EMEA/H/C/233/R/28 (2009)2296 of 25/03/2009
14/05/2009 Centralised - Variation EMEA/H/C/233/IA/29
10/06/2009 Centralised - Variation EMEA/H/C/233/IA/30
13/07/2009 Centralised - Variation EMEA/H/C/233/IA/31
Updated with Decision(2010)2000 of 23/03/2010
30/10/2009 Centralised - Variation EMEA/H/C/233/N/32
Updated with Decision(2010)2000 of 23/03/2010
11/03/2010 Centralised - Variation EMEA/H/C/233/N/33
25/03/2010 Centralised - Variation (2010)2000 of 23/03/2010
22/11/2010 Centralised - Variation EMEA/H/C/233/IA/35
03/01/2011 Centralised - Variation EMEA/H/C/233/N/34
30/07/2013 Centralised - Variation EMEA/H/C/233/N/43
06/12/2013 Centralised - Variation EMEA/H/C/233/IA/44
13/12/2013 Centralised - Variation EMEA/H/C/233/IA/45
18/03/2014 Centralised - Variation EMEA/H/C/233/IB/47