Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: GANIRELIX THERAMEX
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):  (last updated March 3, 2023)
Package information leaflet (PIL): EST  (last updated March 3, 2023)
Labelling:  (last updated March 3, 2023)
Indication: Ganirelix 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: Theramex Ireland Limited 
Marketing authorization number: 1100323 
Marketing authorization issued on: March 3, 2023 
Marketing authorization expires on: March 3, 2028 
Marketing authorization procedure type: Mutual recognition 
Assessment report:   
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1874864  GANIRELIX THERAMEX  solution for injection in pre-filled syringe  0,25mg 0.5ml 0.5ml 1TK  Prescription           
1874875  GANIRELIX THERAMEX  solution for injection in pre-filled syringe  0,25mg 0.5ml 0.5ml 5TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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