Ovaleap

follitropin alfa

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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.

What is Ovaleap and what is it used for?

Ovaleap is a medicine that contains the active substance follitropin alfa. It is used to treat the following groups:

  • women who do not produce eggs and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
  • women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation. Ovaleap is given to stimulate the ovaries to produce more than one egg at a time;
  • women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH). Ovaleap is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
  • men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease). Ovaleap is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production.

Ovaleap is a ‘biosimilar medicine'. This means that Ovaleap is similar to a biological medicine (the ‘reference medicine’) that is already authorised in the European Union (EU) and that Ovaleap and the reference medicine contain the same active substance. The reference medicine for Ovaleap is GONAL-f.

How is Ovaleap used?

Ovaleap is available as a solution for injection. The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems.

Ovaleap is given by injection under the skin once a day. The dose of Ovaleap and how often it is given depend on why it is being used and on the patient’s response to treatment. After the first injection, the patient or their partner may give the injections themselves, if they are well motivated, have been trained and have access to expert advice.

For further information, see the package leaflet.

How does Ovaleap work?

The active substance in Ovaleap, follitropin alfa, is a copy of the natural hormone FSH. In the body, FSH controls reproductive function: in women, it stimulates the production of eggs; and in men, it stimulates the production of sperm in the testicles.

Previously, the FSH used in medicines was extracted from urine. The follitropin alfa in Ovaleap, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology’: it is made by cells into which a gene (DNA) has been introduced that makes them able to produce human FSH.

What benefits of Ovaleap have been shown in studies?

Ovaleap has been compared with GONAL-f in one main study involving 299 women undergoing fertility treatment. The main measure of effectiveness was the number of oocytes (immature eggs) collected.

Ovaleap has been shown to be comparable to the reference medicine, GONAL-f. The average number of oocytes collected was 12.2 in the Ovaleap group, compared with 12.0 in the GONAL-f group.

What are the risks associated with Ovaleap?

The most common side effects with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation). In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10. For the full list of all side effects reported with Ovaleap, see the package leaflet.

Ovaleap must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients. It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary. It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons. In women, Ovaleap must not be used when there is enlargement or a cyst of the ovary caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina. For the full list of restrictions, see the package leaflet.

In some women, the ovaries can over-respond to stimulation. This is called ‘ovarian hyperstimulation syndrome’. Doctors and patients must be aware of this possibility.

Why is Ovaleap approved?

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Ovaleap has been shown to have a comparable quality, safety and efficacy profile to GONAL-f. Therefore, the CHMP’s view was that, as for GONAL-f, Ovaleap’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Ovaleap?

A risk management plan has been developed to ensure that Ovaleap is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ovaleap, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Ovaleap

The European Commission granted a marketing authorisation valid throughout the European Union for Ovaleap on 27 September 2013.

Name Language First published Last updated
Ovaleap : EPAR - Summary for the public BG = bălgarski 2013-10-23  
Ovaleap : EPAR - Summary for the public ES = español 2013-10-23  
Ovaleap : EPAR - Summary for the public CS = čeština 2013-10-23  
Ovaleap : EPAR - Summary for the public DA = dansk 2013-10-23  
Ovaleap : EPAR - Summary for the public DE = Deutsch 2013-10-23  
Ovaleap : EPAR - Summary for the public ET = eesti keel 2013-10-23  
Ovaleap : EPAR - Summary for the public EL = elliniká 2013-10-23  
Ovaleap : EPAR - Summary for the public EN = English 2013-10-23  
Ovaleap : EPAR - Summary for the public FR = français 2013-10-23  
Ovaleap : EPAR - Summary for the public IT = italiano 2013-10-23  
Ovaleap : EPAR - Summary for the public LV = latviešu valoda 2013-10-23  
Ovaleap : EPAR - Summary for the public LT = lietuvių kalba 2013-10-23  
Ovaleap : EPAR - Summary for the public HU = magyar 2013-10-23  
Ovaleap : EPAR - Summary for the public MT = Malti 2013-10-23  
Ovaleap : EPAR - Summary for the public NL = Nederlands 2013-10-23  
Ovaleap : EPAR - Summary for the public PL = polski 2013-10-23  
Ovaleap : EPAR - Summary for the public PT = português 2013-10-23  
Ovaleap : EPAR - Summary for the public RO = română 2013-10-23  
Ovaleap : EPAR - Summary for the public SK = slovenčina 2013-10-23  
Ovaleap : EPAR - Summary for the public SL = slovenščina 2013-10-23  
Ovaleap : EPAR - Summary for the public FI = suomi 2013-10-23  
Ovaleap : EPAR - Summary for the public SV = svenska 2013-10-23  
Ovaleap : EPAR - Summary for the public HR = Hrvatski 2013-10-23  

This EPAR was last updated on 04/08/2016 .

Authorisation details

Product details

Product details for Ovaleap
NameOvaleap
Agency product numberEMEA/H/C/002608
Active substance

follitropin alfa

International non-proprietary name (INN) or common name

follitropin alfa

Therapeutic area Anovulation
Anatomical therapeutic chemical (ATC) code G03GA05
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Biosimilar

A biosimilar medicine is a medicine which is similar to a biological medicine that has already been authorised (the ‘biological reference medicine’). The active substance of a biosimilar medicine similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used in general at the same dose to treat the same disease.

Publication details

Publication details for Ovaleap
Marketing-authorisation holder

Teva Pharma B.V.

Revision4
Date of issue of marketing authorisation valid throughout the European Union27/09/2013

Contact address:

Teva Pharma B.V.
Computerweg 10
3542DR Utrecht
The Netherlands

Product information

Product information

08/07/2016  Ovaleap -EMEA/H/C/002608 -IAIN/0017/G

Name Language First published Last updated
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26
Ovaleap : EPAR - Product Information HR = Hrvatski 2013-10-23 2016-05-26

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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


Name Language First published Last updated
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  
Ovaleap : EPAR - All Authorised presentations HR = Hrvatski 2013-10-23  

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Ovaleap : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2014-06-26 2016-08-04

Initial marketing-authorisation documents

Name Language First published Last updated
Ovaleap : EPAR - Public assessment report HR = Hrvatski 2013-10-23  
CHMP summary of positive opinion for Ovaleap HR = Hrvatski 2013-08-01  

Authorised

This medicine is approved for use in the European Union

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