Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Elonva   
Auth. number : EU/1/09/609
INN : corifollitropin 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: G03GA09 - Corifollitropin alfa
(See WHO ATC Index)
Indication: Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.
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
27/01/2010 Centralised - Authorisation EMEA/H/C/1106 (2010)513 of 25/01/2010
20/04/2010 Centralised - Variation EMEA/H/C/1106/IA/1
Updated with Decision(2010)6010 of 26/08/2010
26/05/2010 Centralised - Variation EMEA/H/C/1106/IA/2/G
27/08/2010 Centralised - Variation EMEA/H/C/1106/IB/3
Updated with Decision(2011)3532 of 16/05/2011
30/08/2010 Centralised - Variation (2010)6010 of 26/08/2010
18/05/2011 Centralised - Variation (2011)3532 of 16/05/2011
13/09/2011 Centralised - Variation EMEA/H/C/1106/N/4
Updated with Decision(2012)1193 of 17/02/2012
22/02/2012 Centralised - Variation EMEA/H/C/1106/IG/117/G
Updated with Decision(2012)1193 of 17/02/2012
22/02/2012 Centralised - Variation (2012)1193 of 17/02/2012
23/09/2013 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1106/T/12 (2013)6209 of 19/09/2013
25/03/2014 Centralised - Variation EMEA/H/C/1106/II/14 (2014)2061 of 21/03/2014
26/08/2014 Centralised - Renewal EMEA/H/C/1106/R/18 (2014)6098 of 22/08/2014