Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Fertavid   
Auth. number : EU/1/09/510
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:

Fertavid 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 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
23/03/2009 Centralised - Authorisation EMEA/H/C/1042 (2009)2126 of 19/03/2009
29/07/2009 Centralised - Variation EMEA/H/C/1042/IA/3
Updated with Decision(2010)917 of 09/02/2010
04/08/2009 Centralised - Variation EMEA/H/C/1042/IB/2
05/10/2009 Centralised - Variation EMEA/H/C/1042/II/1
26/11/2009 Centralised - Variation EMEA/H/C/1042/II/5
11/02/2010 Centralised - Variation EMEA/H/C/1042/II/4 (2010)917 of 09/02/2010
04/06/2010 Centralised - Variation EMEA/H/C/1042/II/6 (2010)3635 of 02/06/2010
02/11/2010 Centralised - Variation EMEA/H/C/1042/WS/33 (2010)7619 of 28/10/2010
06/12/2010 Centralised - Variation EMEA/H/C/1042/WS/34 (2010)8637 of 29/11/2010
31/03/2011 Centralised - Variation EMEA/H/C/1042/WS/72/G
31/03/2011 Centralised - Variation EMEA/H/C/1042/WS/112
31/08/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/1042/T/7 (2011)6238 of 26/08/2011
06/01/2012 Centralised - Variation EMEA/H/C/1042/IA/13/G
Updated with Decision(2012)1279 of 21/02/2012
24/02/2012 Centralised - Variation (2012)1279 of 21/02/2012
28/10/2013 Centralised - Variation EMEA/H/C/1042/N/16
Updated with Decision(2014)1314 of 21/02/2014
13/12/2013 Centralised - Variation EMEA/H/C/1042/IA/20
Updated with Decision(2014)1314 of 21/02/2014
20/02/2014 Centralised - Variation EMEA/H/C/1042/WS/465
25/02/2014 Centralised - Renewal EMEA/H/C/1042/R/17 (2014)1314 of 21/02/2014