Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pergoveris   
Auth. number : EU/1/07/396
Active substance : follitropin alfa / 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: G03GA05 - Follitropin alfa
(See WHO ATC Index)
Indication: Pergoveris is indicated for the stimulation of follicular development in women with severe 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
27/06/2007 Centralised - Authorisation EMEA/H/C/714 (2007)3176 of 25/06/2007
26/02/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/714/II/1
09/04/2008 Centralised - Variation EMEA/H/C/714/II/2 (2008)1338 of 04/04/2008
09/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/714/I/3
19/11/2008 Centralised - Variation EMEA/H/C/714/IA/5
Updated with Decision(2009)4577 of 08/06/2009
19/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/714/IA/4
30/03/2009 Centralised - Variation EMEA/H/C/714/IA/6
Updated with Decision(2009)4577 of 08/06/2009
28/05/2009 Centralised - Notification EMEA/H/C/7414/N/7
Updated with Decision(2010)1513 of 15/03/2010
10/06/2009 Centralised - Variation (2009)4577 of 08/06/2009
25/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/714/II/8
09/07/2009 Centralised - Variation EMEA/H/C/714/IA/10
Updated with Decision(2010)1513 of 15/03/2010
09/07/2009 Centralised - Variation EMEA/H/C/714/IA/9
Updated with Decision(2010)1513 of 15/03/2010
21/01/2010 Centralised - Notification EMEA/H/C/714/N/11
Updated with Decision(2010)3889 of 10/06/2010
02/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/714/II/12
17/03/2010 Centralised - Variation (2010)1513 of 15/03/2010
14/06/2010 Centralised - Variation EMEA/H/C/714/II/13 (2010)3889 of 10/06/2010
25/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/714/WS/16
04/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/714/II/14
06/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/714/IB/15/G
07/07/2011 Centralised - Variation EMEA/H/C/714/IG/76/G
Updated with Decision(2011)6933 of 22/09/2011
26/09/2011 Centralised - Variation (2011)6933 of 22/09/2011
25/05/2012 Centralised - Renewal EMEA/H/C/714/R/21 (2012)3463 of 22/05/2012
12/12/2012 Centralised - Notification EMEA/H/C/714/N/27
Updated with Decision(2015)665 of 03/02/2015
02/10/2013 Centralised - Notification EMEA/H/C/714/N/29
Updated with Decision(2015)665 of 03/02/2015
20/01/2014 Centralised - Variation EMEA/H/C/714/IB/37
Updated with Decision(2015)665 of 03/02/2015
06/02/2015 Centralised - Yearly update (2015)665 of 03/02/2015