Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ovitrelle   
Auth. number : EU/1/00/165
INN : Choriogonadotrophin alfa
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: G03G - Gonadotropins and other ovulation stimulants
Chemical subgroup: G03GA - Gonadotropins
Chemical substance: G03GA01 - Chorionic gonadotrophin
(See WHO ATC Index)
Indication: Ovitrelle is indicated in the treatment of
- Adult women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth,
- Anovulatory or oligoovulatory adult women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligoovulatory women after stimulation of follicular growth.
Marketing Authorisation Holder: Merck 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 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
06/02/2001 Centralised - Authorisation EMEA/H/C/320 (2001)215 of 02/02/2001
12/09/2001 Centralised - Variation EMEA/H/C/320/I/1, 2 (2001)2190 of 10/09/2001
10/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/I/3
10/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/I/6
10/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/I/5, 6
27/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/I/4
22/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/I/8
19/03/2003 Centralised - Notification EMEA/H/C/320/N/9 (2003)858 of 17/03/2003
02/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/II/12
23/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/I/10, 11
28/10/2003 Centralised - Variation EMEA/H/C/320/X/7 (2003)4011 of 24/10/2003
27/11/2003 Centralised - Variation EMEA/H/C/320/IA/13
Updated with Decision(2004)3585 of 20/09/2004
11/03/2004 Centralised - Variation EMEA/H/C/320/IB/14
Updated with Decision(2004)3585 of 20/09/2004
03/08/2004 Centralised - Notification EMEA/H/C/320/N/15
Updated with Decision(2004)3585 of 20/09/2004
22/09/2004 Centralised - Variation (2004)3585 of 20/09/2004
24/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/IA/17
01/12/2004 Centralised - Notification EMEA/H/C/320/N/16
Updated with Decision(2005)4264 of 25/10/2005
25/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/IA/18
05/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/II/19
27/10/2005 Centralised - Variation EMEA/H/C/320/II/21 (2005)4264 of 25/10/2005
07/02/2006 Centralised - Renewal EMEA/H/C/320/R/20 (2006)309 of 31/01/2006
11/08/2006 Centralised - Notification EMEA/H/C/320/N/22
Updated with Decision(2009)4467 of 04/06/2009
20/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/II/23
16/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/IB/25
26/06/2007 Centralised - Notification EMEA/H/C/320/N/26
Updated with Decision(2009)4467 of 04/06/2009
08/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/II/24, 27
02/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/IA/30
09/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/IB/29
28/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/II/28
12/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/IA/33
06/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/II/31
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/II/32
07/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/IB/34
07/11/2008 Centralised - Variation EMEA/H/C/320/IA/35
Updated with Decision(2009)4467 of 04/06/2009
02/04/2009 Centralised - Variation EMEA/H/C/320/IA/36
Updated with Decision(2009)4467 of 04/06/2009
08/06/2009 Centralised - Variation (2009)4467 of 04/06/2009
09/07/2009 Centralised - Variation EMEA/H/C/320/IA/37
Updated with Decision(2010)1779 of 15/03/2010
23/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/320/IB/38
25/01/2010 Centralised - Notification EMEA/H/C/320/N/39
Updated with Decision(2011)4618 of 23/06/2011
17/03/2010 Centralised - Variation (2010)1779 of 15/03/2010
27/06/2011 Centralised - Variation EMEA/H/C/320/X/40 (2011)4618 of 23/06/2011
21/10/2011 Centralised - Variation EMEA/H/C/320/IB/41
Updated with Decision(2012)3142 of 07/05/2012
09/05/2012 Centralised - Variation (2012)3142 of 07/05/2012
14/12/2012 Centralised - Variation EMEA/H/C/320/IB/50
Updated with Decision(2013)9655 of 17/12/2013
07/11/2013 Centralised - Notification EMEA/H/C/320/N/55
Updated with Decision(2013)9655 of 17/12/2013
20/12/2013 Centralised - Yearly update (2013)9655 of 17/12/2013
25/04/2014 Centralised - Variation EMEA/H/C/320/IB/60