Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ovaleap   
Auth. number : EU/1/13/871
Active substance : 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: In adult women
• Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate.
• Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra fallopian transfer.
• Ovaleap 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.
In adult men
• Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland
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
01/10/2013 Centralised - Authorisation EMEA/H/C/2608 (2013)6429 of 27/09/2013
12/05/2014 Centralised - Variation EMEA/H/C/2608/IB/1
Updated with Decision(2014)6741 of 16/09/2014
18/09/2014 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/2608/T/5 (2014)6741 of 16/09/2014
23/03/2016 Centralised - Variation EMEA/H/C/2608/IAIN/14
Updated with Decision(2017)2545 of 12/04/2017
08/07/2016 Centralised - Variation EMEA/H/C/2608/IAIN/17/G
Updated with Decision(2017)2545 of 12/04/2017
19/04/2017 Centralised - Yearly update (2017)2545 of 12/04/2017
14/07/2017 Centralised - Variation EMEA/H/C/2608/IA/19
Updated with Decision(2018)3154 of 16/05/2018
11/08/2017 Centralised - Variation EMEA/H/C/2608/IB/21
Updated with Decision(2018)3154 of 16/05/2018
18/05/2018 Centralised - Renewal EMEA/H/C/2608/R/23 (2018)3154 of 16/05/2018