Product class: Authorized package
Medicinal product class: For human use
Package code: 1888173
Name of medicinal product: GANIRELIX GEDEON RICHTER
Active substances:
Ganirelix
Estonian, English, Latin
ATC code: H01CC01
Dosage form: solution for injection in pre-filled syringe
Route of administration: subcutaneous use
Strengh: 0,25mg 0.5ml
Amount in package: 0.5ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Ganirelix Gedeon Richter is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART). In clinical studies ganirelix was used with recombinant human follicle stimulating hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: 07 June 2024
Marketing authorization holder: Gedeon Richter Plc. 
Marketing authorization number: EU/1/22/1658 
Marketing authorization issued on: 15 July 2022 
Marketing authorization expires on: 19 July 2027 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  13/07/2024     Yes      No      
100  13/07/2024     Yes  N97.0-N97.9; Z31.0-Z31.9    No  until 41 years  kehavälise viljastamise ja embrüo siirdamise tervishoiuteenuste osutamise ettevalmistuseks 
100  13/07/2024     Yes      No  until 4 years   
100  13/07/2024     Yes  N97.0-N97.9; Z31.0-Z31.9    No  until 4 years  kehavälise viljastamise ja embrüo siirdamise tervishoiuteenuste osutamise ettevalmistuseks 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 07 July 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription