Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: GONAL-f   
Auth. number : EU/1/95/001
INN : Follitropin 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: - Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate.- Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).- GONAL-f in association with a luteinising hormone (LH) preparation is recommended 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.- GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.
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
26/10/1995 Centralised - Authorisation EMEA/H/C/71 (95)2574 of 20/10/1995
01/07/1996 Centralised - Variation EMEA/H/C/71/I/1 (96)1748 of 28/06/1996
15/07/1996 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/71/T/2 (96)1934 of 11/07/1996
21/01/1997 Centralised - Variation EMEA/H/C/71/I/3 (97)159 of 20/01/1997
01/10/1997 Centralised - Variation EMEA/H/C/71/I/6 (97)2922 of 30/09/1997
20/07/1998 Centralised - Variation EMEA/H/C/71/N/15 (1998)2060 of 17/07/1998
30/06/1999 Centralised - Authorisation EMEA/H/C/71/X/15 (1999)1654 of 18/06/1999
30/06/1999 Centralised - Variation EMEA/H/C/71/II/17, 18 (1999)1654 of 18/06/1999
15/12/1999 Centralised - Variation EMEA/H/C/71/N/21 (1999)4280 of 08/12/1999
22/03/2000 Centralised - Variation EMEA/H/C/71/I/23, 24 (2000)724 of 16/03/2000
02/08/2000 Centralised - Variation EMEA/H/C/71/I/20
02/01/2001 Centralised - Renewal EMEA/H/C/71/R/25 (2000)4302 of 29/12/2000
30/01/2001 Centralised - Variation EMEA/H/C/71/I/29
30/01/2001 Centralised - Variation EMEA/H/C/71/X/22 (2001)98 of 29/01/2001
30/01/2001 Centralised - Variation EMEA/H/C/71/I/29
07/03/2001 Centralised - Variation EMEA/H/C/71/I/31 (2001)309 of 05/03/2001
03/05/2001 Centralised - Variation EMEA/H/C/71/I/32
22/06/2001 Centralised - Variation EMEA/H/C/71/II/26, 27 (2001)1336 of 20/06/2001
06/07/2001 Centralised - Variation EMEA/H/C/71/I/43
23/07/2001 Centralised - Variation EMEA/H/C/71/I/33 (2001)2033 of 20/07/2001
25/07/2001 Centralised - Variation EMEA/H/C/71/I/36
25/07/2001 Centralised - Variation EMEA/H/C/71/I/35
24/09/2001 Centralised - Variation EMEA/H/C/71/II/30
12/11/2001 Centralised - Variation EMEA/H/C/71/I/45 (2001)3512 of 07/11/2001
30/01/2002 Centralised - Variation EMEA/H/C/71/I/46 (2002)405 of 28/01/2002
21/02/2002 Centralised - Variation EMEA/H/C/71/I/47 (2002)635 of 19/02/2002
12/06/2002 Centralised - Variation EMEA/H/C/71/II/44 (2002)2171 of 07/06/2002
13/06/2002 Centralised - Variation EMEA/H/C/71/X/41 (2002)2170 of 07/06/2002
13/06/2002 Centralised - Variation EMEA/H/C/71/II/37, 40 (2002)2169 of 07/06/2002
28/06/2002 Centralised - Variation EMEA/H/C/71/II/48
09/07/2002 Centralised - Variation EMEA/H/C/71/I/50
17/07/2002 Centralised - Variation EMEA/H/C/71/I/52
19/07/2002 Centralised - Variation EMEA/H/C/71/I/51
10/09/2002 Centralised - Variation EMEA/H/C/71/I/54
27/09/2002 Centralised - Variation EMEA/H/C/71/II/49
04/10/2002 Centralised - Variation EMEA/H/C/71/I/53 (2002)3705 of 02/10/2002
11/10/2002 Centralised - Variation EMEA/H/C/71/I/55
22/01/2003 Centralised - Variation EMEA/H/C/71/I/57
27/03/2003 Centralised - Variation EMEA/H/C/71/N/58 (2003)1036 of 24/03/2003
22/09/2003 Centralised - Variation EMEA/H/C/71/I/63
23/10/2003 Centralised - Variation EMEA/H/C/71/I/62
15/12/2003 Centralised - Variation EMEA/H/C/71/I/61
Updated with Decision(2004)2240 of 17/06/2004
16/01/2004 Centralised - Variation EMEA/H/C/71/II/60 (2004)95 of 14/01/2004
26/02/2004 Centralised - Variation EMEA/H/C/71/X/59 (2004)621 of 23/02/2004
04/06/2004 Centralised - Variation EMEA/H/C/71/IB/64
21/06/2004 Centralised - Variation (2004)2240 of 17/06/2004
01/07/2004 Centralised - Variation EMEA/H/C/71/IB/65
Updated with Decision(2005)812 of 10/03/2005
24/11/2004 Centralised - Variation EMEA/H/C/71/IA/66
17/12/2004 Centralised - Variation EMEA/H/C/71/IA/69
17/12/2004 Centralised - Variation EMEA/H/C/71/IA/68
17/12/2004 Centralised - Variation EMEA/H/C/71/IA/70
17/12/2004 Centralised - Variation EMEA/H/C/71/IA/68
06/01/2005 Centralised - Variation EMEA/H/C/71/IB/71
14/03/2005 Centralised - Variation (2005)812 of 10/03/2005
23/03/2005 Centralised - Variation EMEA/H/C/71/IB/75
15/04/2005 Centralised - Variation EMEA/H/C/71/IA/77
27/04/2005 Centralised - Variation EMEA/H/C/71/II/72 (2005)1347 of 25/04/2005
13/05/2005 Centralised - Variation EMEA/H/C/71/IB/76
21/10/2005 Centralised - Renewal EMEA/H/C/71/R/78 (2005)4164 of 19/10/2005
09/12/2005 Corrigendum EMEA/H/C/71/R/78
01/03/2006 Centralised - Variation EMEA/H/C/71/II/83
04/05/2006 Centralised - Variation EMEA/H/C/71/II/79
08/05/2006 Centralised - Variation EMEA/H/C/71/IB/86
12/05/2006 Centralised - Variation EMEA/H/C/71/II/84 (2006)1966 of 10/05/2006
07/06/2006 Centralised - Variation EMEA/H/C/71/II/80
28/06/2006 Centralised - Variation EMEA/H/C/71/II/81 (2006)3000 of 26/06/2006
26/07/2006 Centralised - Variation EMEA/H/C/71/II/85 (2006)3381 of 20/07/2006
01/08/2006 Centralised - Variation EMEA/H/C/71/IB/88
09/08/2006 Centralised - Variation EMEA/H/C/71/IA/89
Updated with Decision(2007)1354 of 21/03/2007
23/03/2007 Centralised - Variation (2007)1354 of 21/03/2007
12/10/2007 Centralised - Variation EMEA/H/C/71/N/90
Updated with Decision(2007)6871 of 21/12/2007
02/01/2008 Centralised - Variation EMEA/H/C/71/II/91 (2007)6871 of 21/12/2007
15/04/2008 Centralised - Variation EMEA/H/C/71/IA/94
21/05/2008 Centralised - Variation EMEA/H/C/71/IA/95
05/06/2008 Centralised - Variation EMEA/H/C/71/II/93
04/07/2008 Centralised - Variation EMEA/H/C/71/IA/96
13/10/2008 Centralised - Variation EMEA/H/C/71/IA/98
Updated with Decision(2009)4605 of 09/06/2009
13/10/2008 Centralised - Variation EMEA/H/C/71/IA/97
Updated with Decision(2009)4605 of 09/06/2009
19/11/2008 Centralised - Variation EMEA/H/C/71/IB/100
23/01/2009 Centralised - Variation EMEA/H/C/71/N/99
Updated with Decision(2009)4605 of 09/06/2009
31/03/2009 Centralised - Variation EMEA/H/C/71/IA/103
Updated with Decision(2009)4605 of 09/06/2009
11/06/2009 Centralised - Variation EMEA/H/C/71/II/104
11/06/2009 Centralised - Variation EMEA/H/C/71/II/101
11/06/2009 Centralised - Variation (2009)4605 of 09/06/2009
30/07/2009 Centralised - Variation EMEA/H/C/71/II/102 (2009)6067 of 24/07/2009
17/09/2009 Centralised - Variation EMEA/H/C/71/IA/106
Updated with Decision(2010)1802 of 15/03/2010
17/09/2009 Centralised - Variation EMEA/H/C/71/IA/105
Updated with Decision(2010)1802 of 15/03/2010
17/03/2010 Centralised - Variation (2010)1802 of 15/03/2010
27/04/2010 Centralised - Variation EMEA/H/C/71/N/108
Updated with Decision(2010)5333 of 27/07/2010
30/07/2010 Centralised - Renewal EMEA/H/C/71/R/107 (2010)5333 of 27/07/2010
26/05/2011 Centralised - Variation EMEA/H/C/71/II/109/G (2011)3718 of 23/05/2011
01/12/2011 Centralised - Variation EMEA/H/C/71/IB/111
Updated with Decision(2012)4582 of 28/06/2012
03/07/2012 Centralised - Variation (2012)4582 of 28/06/2012
28/10/2013 Centralised - Variation EMEA/H/C/71/N/118
07/04/2014 Centralised - Variation EMEA/H/C/71/IB/125