Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Luveris   
Auth. number : EU/1/00/155
Active substance : Lutropin 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: G03GA07 - Lutropin alfa
(See WHO ATC Index)
Indication: Luveris in association with a Follicle Stimulating Hormone (FSH) preparation is recommended for the stimulation of follicular development in adult women with severe Luteinising Hormone (LH) and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/l.
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
30/11/2000 Centralised - Authorisation EMEA/H/C/292 (2000)3398 of 29/11/2000
21/05/2001 Centralised - Variation EMEA/H/C/292/I/1 (2001)1229 of 17/05/2001
05/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/3
03/09/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/7
14/09/2001 Centralised - Variation EMEA/H/C/292/I/5 (2001)2200 of 13/09/2001
02/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/11
05/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/4
05/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/9
05/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/8
23/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/14
30/01/2002 Centralised - Variation EMEA/H/C/292/I/12 (2002)404 of 28/01/2002
17/05/2002 Centralised - Variation EMEA/H/C/292/II/6 (2002)1938 of 15/05/2002
18/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/15
04/12/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/16
22/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/17
06/03/2003 Centralised - Notification EMEA/H/C/292/N/18 (2003)758 of 04/03/2003
14/05/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/19
02/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/II/20
24/09/2003 Centralised - Variation EMEA/H/C/292/I/22 (2003)3421 of 22/09/2003
15/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/I/21
15/01/2004 Centralised - Variation EMEA/H/C/292/IB/23
Updated with Decision(2004)3386 of 31/08/2004
27/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/II/24
01/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/II/25
27/07/2004 Centralised - Notification EMEA/H/C/292/N/27
Updated with Decision(2004)3386 of 31/08/2004
02/09/2004 Centralised - Variation EMEA/H/C/292 (2004)3386 of 31/08/2004
22/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/II/26
28/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/IA/29
26/11/2004 Centralised - Notification EMEA/H/C/292/N/28
Updated with Decision(2006)203 of 24/01/2006
02/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/IA/30
10/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/IB/32
10/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/IB/31
26/01/2006 Centralised - Renewal EMEA/H/C/292/R/33 (2006)203 of 24/01/2006
26/06/2007 Centralised - Notification EMEA/H/C/292/N/35
Updated with Decision(2009)4221 of 26/05/2009
20/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/IA/36
01/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/IB/39
02/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/II/38
27/10/2008 Centralised - Variation EMEA/H/C/292/IA/40
Updated with Decision(2009)4221 of 26/05/2009
26/02/2009 Centralised - Variation EMEA/H/C/292/IA/41
Updated with Decision(2009)4221 of 26/05/2009
28/05/2009 Centralised - Variation EMEA/H/C/292/X/37 (2009)4221 of 26/05/2009
09/07/2009 Centralised - Variation EMEA/H/C/292/IA/42
Updated with Decision(2010)1801 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1801 of 15/03/2010
21/06/2010 Centralised - Variation EMEA/H/C/292/II/43 (2010)4210 of 17/06/2010
25/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/292/WS/16
23/03/2011 Centralised - Variation EMEA/H/C/292/II/45 (2011)1922 of 18/03/2011
25/05/2011 Centralised - Variation EMEA/H/C/292/II/44/G (2011)3710 of 23/05/2011
27/10/2011 Centralised - Variation EMEA/H/C/292/IB/46
Updated with Decision(2012)3297 of 14/05/2012
16/05/2012 Centralised - Variation (2012)3297 of 14/05/2012
14/01/2013 Centralised - Variation EMEA/H/C/292/IB/54
Updated with Decision(2013)9736 of 18/12/2013
07/11/2013 Centralised - Notification EMEA/H/C/292/N/7
Updated with Decision(2013)9736 of 18/12/2013
23/12/2013 Centralised - Yearly update (2013)9736 of 18/12/2013
18/03/2014 Centralised - Variation EMEA/H/C/292/IB/61
Updated with Decision(2015)2934 of 24/04/2015
19/11/2014 Centralised - Variation EMEA/H/C/292/IB/67
Updated with Decision(2015)2934 of 24/04/2015
28/04/2015 Centralised - Yearly update (2015)2934 of 24/04/2015