AMELGEN
General data
Product class:
Authorized package
Medicinal product class:
For human use
Package code:
1757774
Name of medicinal product:
AMELGEN
Active substances:
Progesterone
Estonian
,
English
,
Latin
ATC code:
G03DA04
Dosage form:
pessary
Route of administration:
vaginal use
Strengh:
400mg
Amount in package:
30TK
Legal status for supply*:
Subject to medicinal prescription
Class of active substance:
Additional information:
Indication:
/…/ is indicated for luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women.
Safety features:
Yes
Summary of product characteristics (SPC):
(last updated 03 November 2021)
Package information leaflet (PIL):
EST
(last updated 12 June 2023)
Labelling:
(last updated 16 May 2019)
Last imported to Estonia:
Never imported to Estonia
Marketing authorization
Marketing authorization holder:
Gedeon Richter Plc.
Marketing authorization number:
952317
Marketing authorization issued on:
11 October 2017
Marketing authorization expires on:
Unlimited
Marketing authorization procedure type:
Decentralised
Prices
Reference price:
Under reference price:
Reference price of daily dose:
Entry/Changing date: 12 June 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription