Product class: Authorized package
Medicinal product class: For human use
Package code: 1012059
Name of medicinal product: ORGALUTRAN
Active substances:
Estonian, English, Latin
ATC code: H01CC01
Dosage form: solution for injection
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: Orgalutran 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 Orgalutran 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
Last imported to Estonia: 05 October 2018
Marketing authorization holder: Organon N.V. 
Marketing authorization number: EU/1/00/130 
Marketing authorization issued on: 21 December 2000 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 06 May 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription