Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ORGALUTRAN
Active substances:
Estonian, English, Latin
ATC code: H01CC01
Dosage form: solution for injection
Strength: 0,25mg 0.5ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
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
Marketing authorization holder: Organon N.V. 
Marketing authorization number: EU/1/00/130 
Marketing authorization issued on: December 21, 2000 
Marketing authorization expires on: Unlimited 
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
1012059  ORGALUTRAN  solution for injection  0,25mg 0.5ml 0.5ml 1TK  Prescription      05.10.2018     
1064685  ORGALUTRAN  solution for injection  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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