Product class: Authorized package
Medicinal product class: For human use
Package code: 1757785
Name of medicinal product: AMELGEN
Active substances:
Estonian, English, Latin
ATC code: G03DA04
Dosage form: pessary
Route of administration: vaginal use
Strengh: 400mg
Amount in package: 45TK
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 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 
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