Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1043356
Name of medicinal product: CETROTIDE
Active substances:
Cetrorelix
Estonian, English, Latin
ATC code: H01CC02
Dosage form: powder and solvent for solution for injection
Route of administration: subcutaneous use
Strengh: 0,25mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: lahusti süstlis 1 ml
Indication: Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques. In clinical trials Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: August 30, 2022
Marketing authorization holder: Merck Europe B.V. 
Marketing authorization number: EU/1/99/100 
Marketing authorization issued on: August 27, 1999 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
50  04.07.2022  01.10.2022  Yes      No      
100  04.07.2022  01.10.2022  Yes      No  until 4 years   
100  04.07.2022  01.10.2022  Yes  N97.0-N97.9; Z31.0-Z31.9    No  until 4 years  kehavälise viljastamise ja embrüo siirdamise tervishoiuteenuste osutamise ettevalmistuseks 
100  04.07.2022  01.10.2022  Yes  N97.0-N97.9; Z31.0-Z31.9    No  until 41 years  kehavälise viljastamise ja embrüo siirdamise tervishoiuteenuste osutamise ettevalmistuseks 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: September 5, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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