Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1874864
Name of medicinal product: GANIRELIX THERAMEX
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 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):  (last updated March 3, 2023)
Package information leaflet (PIL): EST  (last updated March 3, 2023)
Labelling:  (last updated March 3, 2023)
Last imported to Estonia: Never imported to Estonia
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: April 12, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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