Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
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
Strength: 0,25mg 0.5ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
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
Marketing authorization holder: Gedeon Richter Plc. 
Marketing authorization number: EU/1/22/1658 
Marketing authorization issued on: July 15, 2022 
Marketing authorization expires on: July 19, 2027 
Marketing authorization procedure type: Centralised 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1888173  GANIRELIX GEDEON RICHTER  solution for injection in pre-filled syringe  0,25mg 0.5ml 0.5ml 1TK  Prescription  100% 50%    07.06.2024     
1888184  GANIRELIX GEDEON RICHTER  solution for injection in pre-filled syringe  0,25mg 0.5ml 0.5ml 6TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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