Ganirelix Gedeon Richter
ganirelix
Table of contents
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.
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Ganirelix Gedeon Richter - EPAR - Medicine overview (PDF/100.24 KB)
First published: 20/07/2022
EMA/558572/2022 -
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Ganirelix Gedeon Richter : EPAR - Risk-management-plan summary (PDF/91.71 KB)
First published: 20/07/2022
Authorisation details
Product details | |
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Name |
Ganirelix Gedeon Richter
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Agency product number |
EMEA/H/C/005641
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Active substance |
ganirelix acetate
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International non-proprietary name (INN) or common name |
ganirelix
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
H01CC01
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Generic |
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 | |
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Marketing-authorisation holder |
Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.)
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Date of issue of marketing authorisation valid throughout the European Union |
15/07/2022
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Contact address |
Gyomroi ut 19-21 |
Product information
15/07/2022 Ganirelix Gedeon Richter - EMEA/H/C/005641 -
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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).
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).