Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Orgalutran   
Auth. number : EU/1/00/130
INN : ganirelix
ATC: Anatomical main group: H - Systemic hormonal prep, excluding sex hormones
Therapeutic subgroup: H01 - Pituitary and hypothalamic hormones
Pharmacological subgroup: H01C - Hypothalamic hormones
Chemical subgroup: H01CC - Anti-gonadotropin-releasing hormones
Chemical substance: H01CC01 - Ganirelix
(See WHO ATC Index)
Indication: Prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART)
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 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
22/05/2000 Centralised - Authorisation EMEA/H/C/274 (2000)1245 of 17/05/2000
13/03/2001 Centralised - Variation EMEA/H/C/274/I/1
21/09/2001 Centralised - Variation EMEA/H/C/274/I/2 (2001)2712 of 18/09/2001
22/04/2002 Centralised - Variation EMEA/H/C/274/II/4 (2002)1544 of 18/04/2002
09/01/2003 Centralised - Variation EMEA/H/C/274/II/5
02/04/2003 Centralised - Variation EMEA/H/C/274/I/6
02/04/2003 Centralised - Variation EMEA/H/C/274/I/6
23/07/2003 Centralised - Variation EMEA/H/C/274/N/8 (2003)2717 of 18/07/2003
17/08/2004 Centralised - Variation EMEA/H/C/274/N/9
Updated with Decision(2005)572 of 03/03/2005
07/03/2005 Centralised - Renewal EMEA/H/C/274/R/10 (2005)572 of 03/03/2005
27/10/2005 Centralised - Variation EMEA/H/C/274/II/11 (2005)4258 of 25/10/2005
13/04/2007 Centralised - Variation EMEA/H/C/274/IA/13
06/06/2007 Centralised - Variation EMEA/H/C/274/II/12 (2007)2450 of 04/06/2007
22/01/2008 Centralised - Variation EMEA/H/C/274/II/14 (2008)304 of 18/01/2008
02/07/2009 Centralised - Variation EMEA/H/C/274/II/15
21/08/2009 Centralised - Variation EMEA/H/C/274/IA/17
22/01/2010 Centralised - Variation EMEA/H/C/274/II/16 (2010)401 of 20/01/2010
12/05/2010 Centralised - Renewal EMEA/H/C/274/R/18 (2010)3158 of 10/05/2010
11/11/2010 Centralised - Variation EMEA/H/C/274/IB/20
Updated with Decision(2011)558 of 27/01/2011
31/01/2011 Centralised - Variation EMEA/H/C/274/II/19 (2011)558 of 27/01/2011
29/07/2011 Centralised - Variation EMEA/H/C/274/N/22
Updated with Decision(2012)6393 of 10/09/2012
22/12/2011 Centralised - Variation EMEA/H/C/274/N/24
Updated with Decision(2012)6393 of 10/09/2012
12/09/2012 Centralised - Variation EMEA/H/C/274/II/25 (2012)6393 of 10/09/2012
15/08/2013 Centralised - Variation EMEA/H/C/274/N/28
23/09/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/274/T/27 (2013)6223 of 19/09/2013