Ganirelix Gedeon Richter

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ganirelix

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

Overview

Ganirelix Gedeon Richter is a medicine used to prevent premature ovulation (early release of eggs from the ovary) in women having fertility treatment and who are having ovarian stimulation (stimulation of the ovaries so that they produce more eggs).

Ganirelix Gedeon Richter contains the active substance ganirelix and is a ‘generic medicine’. This means that the medicine contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Orgalutran. For more information on generic medicines, see the question-and-answer document here.

This EPAR was last updated on 20/07/2022

Authorisation details

Product details
Name
Ganirelix Gedeon Richter
Agency product number
EMEA/H/C/005641
Active substance
ganirelix acetate
International non-proprietary name (INN) or common name
ganirelix
Therapeutic area (MeSH)
  • Reproductive Techniques, Assisted
  • Ovulation Induction
  • Infertility, Female
Anatomical therapeutic chemical (ATC) code
H01CC01
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
Date of issue of marketing authorisation valid throughout the European Union
15/07/2022
Contact address

Gyomroi ut 19-21
1103 Budapest
Hungary

Product information

15/07/2022 Ganirelix Gedeon Richter - EMEA/H/C/005641 -

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

Prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

Assessment history

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