This is a summary of the European public assessment report (EPAR) for Ovaleap. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Ovaleap.
For practical information about using Ovaleap, patients should read the package leaflet or contact their doctor or pharmacist.
Ovaleap : EPAR - Summary for the public (PDF/82.51 KB)
First published: 23/10/2013
Last updated: 23/10/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Theramex Ireland Limited
|Date of issue of marketing authorisation valid throughout the European Union||
3rd Floor, Kilmore House
16/08/2023 Ovaleap - EMEA/H/C/002608 - IB/0038
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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Sex hormones and modulators of the genital system
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.