Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Puregon   
Auth. number : EU/1/96/008
INN : follitropin beta
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: G03GA06 - Follitropin beta
(See WHO ATC Index)
Indication: In the female:Puregon is indicated for the treatment of female infertility in the following clinical situations:- Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate.- Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].In the male:- Deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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
07/05/1996 Centralised - Authorisation EMEA/H/C/86 (96)1105 of 03/05/1996
29/11/1996 Centralised - Variation EMEA/H/C/86/I/1 (96)3513 of 28/11/1996
21/01/1997 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/86/T (97)162 of 20/01/1997
04/04/1997 Centralised - Variation EMEA/H/C/86/I/5, 6, 7 (97)936 of 03/04/1997
08/10/1998 Centralised - Variation EMEA/H/C/86/II/8 (1998)2831 of 05/10/1998
07/05/1999 Centralised - Authorisation EMEA/H/C/86/X/9 (1999)1038 of 26/04/1999
12/07/1999 Centralised - Variation EMEA/H/C/86/N/12 (1999)1909 of 08/07/1999
17/02/2000 Centralised - Authorisation EMEA/H/C/86/X/10 (2000)313 of 10/02/2000
23/02/2000 Centralised - Variation EMEA/H/C/86/II/11, 14 (2000)422 of 21/02/2000
20/07/2000 Centralised - Variation EMEA/H/C/86/N/17 (2000)1787 of 11/07/2000
28/08/2000 Centralised - Variation EMEA/H/C/86/I/19
11/12/2000 Centralised - Variation EMEA/H/C/86/II/16,18 (2000)3499 of 08/12/2000
11/12/2000 Centralised - Variation EMEA/H/C/86/I/21
18/01/2001 Centralised - Variation EMEA/H/C/86/I/22 (2001)8 of 15/01/2001
12/04/2001 Centralised - Variation EMEA/H/C/86/II/23 (2001)831 of 10/04/2001
27/07/2001 Centralised - Renewal EMEA/H/C/86/R/24 (2001)2037 of 26/07/2001
19/10/2001 Centralised - Variation EMEA/H/C/86/I/27 (2001)2853 of 18/10/2001
07/02/2002 Centralised - Variation EMEA/H/C/86/II/26 (2002)482 of 05/02/2002
12/03/2002 Centralised - Variation EMEA/H/C/86/N/28 (2002)1029 of 08/03/2002
19/03/2002 Centralised - Variation EMEA/H/C/86/II/29
04/06/2002 Centralised - Variation EMEA/H/C/86/II/30
06/06/2002 Centralised - Variation EMEA/H/C/86/I/32
02/07/2002 Centralised - Variation EMEA/H/C/86/I/31
30/10/2002 Centralised - Variation EMEA/H/C/86/II/33 (2002)4334 of 28/10/2002
31/03/2003 Centralised - Variation EMEA/H/C/86/II/34
21/08/2003 Centralised - Variation EMEA/H/C/86/N/35 (2003)3093 of 19/08/2003
22/09/2003 Centralised - Variation EMEA/H/C/86/I/37
30/09/2003 Centralised - Variation EMEA/H/C/86/I/36
17/03/2004 Centralised - Variation EMEA/H/C/86/IB/39
Updated with Decision(2004)3041 of 02/08/2004
04/08/2004 Centralised - Variation EMEA/H/C/86/II/38 (2004)3041 of 02/08/2004
04/08/2004 Centralised - Variation EMEA/H/C/86/II/41 (2004)3042 of 02/08/2004
22/10/2004 Centralised - Variation EMEA/H/C/86/II/42 (2004)4186 of 20/10/2004
07/12/2004 Centralised - Variation EMEA/H/C/86/IB/44
20/07/2005 Centralised - Variation EMEA/H/C/86/IA/45
21/12/2005 Centralised - Variation EMEA/H/C/86/II/47
31/05/2006 Centralised - Renewal EMEA/H/C/86/R/48 (2006)2188 of 29/05/2006
07/06/2006 Centralised - Variation EMEA/H/C/86/II/50
21/07/2006 Centralised - Variation EMEA/H/C/86/IB/52
21/07/2006 Centralised - Variation EMEA/H/C/86/IB/54
31/08/2006 Centralised - Variation EMEA/H/C/86/IB/53
27/09/2006 Centralised - Variation EMEA/H/C/86/II/49
11/01/2007 Centralised - Variation EMEA/H/C/86/II/55 (2007)87 of 09/01/2007
25/04/2007 Centralised - Variation EMEA/H/C/86/IA/56
Updated with Decision(2008)30 of 08/01/2008
27/09/2007 Centralised - Variation EMEA/H/C/86/II/57
10/01/2008 Centralised - Variation (2008)30 of 08/01/2008
24/06/2008 Centralised - Variation EMEA/H/C/86/II/59 (2008)3198 of 20/06/2008
09/09/2008 Centralised - Variation EMEA/H/C/86/II/58 (2008)5016 of 05/09/2008
17/11/2008 Centralised - Variation EMEA/H/C/86/IB/60
10/03/2009 Centralised - Variation EMEA/H/C/86/II/61
24/03/2009 Centralised - Variation EMEA/H/C/86/II/62
16/07/2009 Centralised - Variation EMEA/H/C/86/IA/64
Updated with Decision(2009)9454 of 23/11/2009
25/11/2009 Centralised - Variation EMEA/H/C/86/II/63 (2009)9454 of 23/11/2009
08/12/2009 Centralised - Variation EMEA/H/C/86/II/65
27/10/2010 Centralised - Variation EMEA/H/C/86/WS/33 (2010)7529 of 25/10/2010
06/12/2010 Centralised - Variation EMEA/H/C/86/WS/34 (2010)8642 of 29/11/2010
15/04/2011 Centralised - Variation EMEA/H/C/86/WS/72/G
15/04/2011 Centralised - Variation EMEA/H/C/86/WS/112
15/07/2011 Centralised - Variation EMEA/H/C/86/N/66
Updated with Decision(2012)2174 of 26/03/2012
05/09/2011 Centralised - Variation EMEA/H/C/86/IB/67/G
Updated with Decision(2012)2174 of 26/03/2012
03/01/2012 Centralised - Variation EMEA/H/C/86/N/72
Updated with Decision(2012)2174 of 26/03/2012
18/01/2012 Centralised - Variation EMEA/H/C/86/IA/71/G
Updated with Decision(2012)2174 of 26/03/2012
28/03/2012 Centralised - Variation (2012)2174 of 26/03/2012
16/09/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/86/T/75 (2013)5931 of 12/09/2013
13/12/2013 Centralised - Variation EMEA/H/C/86/IA/78/G
13/12/2013 Centralised - Variation EMEA/H/C/86/IA/78/G
20/02/2014 Centralised - Variation EMEA/H/C/8/WS/465