Ovaleap

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follitropin alfa

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 13/12/2018

Authorisation details

Product details
Name
Ovaleap
Agency product number
EMEA/H/C/002608
Active substance
follitropin alfa
International non-proprietary name (INN) or common name
follitropin alfa
Therapeutic area (MeSH)
Anovulation
Anatomical therapeutic chemical (ATC) code
G03GA05
BiosimilarBiosimilar

This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

Publication details
Marketing-authorisation holder
Teva Pharma B.V.
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
27/09/2013
Contact address
Computerweg 10
3542 DR Utrecht
The Netherlands

Product information

26/10/2018 Ovaleap - EMEA/H/C/002608 - N/0026

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic 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.

Assessment history

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