Product class:
|
Authorized package
|
Medicinal product class:
|
For human use
|
Package code:
|
1043356
|
Name of medicinal product:
|
CETROTIDE
|
Active substances:
|
|
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:
|
04 March 2024
|
Marketing authorization holder:
|
Merck Europe B.V.
|
Marketing authorization number:
|
EU/1/99/100
|
Marketing authorization issued on:
|
27 August 1999
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Percent
|
Valid from
|
Valid until
|
Valid
|
Diagnosis
|
Doctor's speciality
|
Primary
|
Age
|
Other
|
100
|
01/01/2024
|
01/04/2024
|
Yes
|
N97.0-N97.9; Z31.0-Z31.9
|
|
No
|
until 4 years
|
kehavälise viljastamise ja embrüo siirdamise tervishoiuteenuste osutamise ettevalmistuseks
|
100
|
01/01/2024
|
01/04/2024
|
Yes
|
N97.0-N97.9; Z31.0-Z31.9
|
|
No
|
until 41 years
|
kehavälise viljastamise ja embrüo siirdamise tervishoiuteenuste osutamise ettevalmistuseks
|
100
|
01/01/2024
|
01/04/2024
|
Yes
|
|
|
No
|
until 4 years
|
|
50
|
01/01/2024
|
01/04/2024
|
Yes
|
|
|
No
|
|
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Entry/Changing date:
05 September 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription