Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: AMELGEN
Active substances:
Estonian, English, Latin
ATC code: G03DA04
Dosage form: pessary
Strength: 400mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated November 3, 2021)
Package information leaflet (PIL): EST  (last updated June 12, 2023)
Labelling:  (last updated May 16, 2019)
Indication: /…/ is indicated for luteal phase support as part of an Assisted Reproductive Technology (ART) treatment for women.
Safety features: Yes
Marketing authorization holder: Gedeon Richter Plc. 
Marketing authorization number: 952317 
Marketing authorization issued on: October 11, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated October 11, 2017) 
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1708556  AMELGEN  pessary  400mg 12TK  Prescription           
1708567  AMELGEN  pessary  400mg 15TK  Prescription      13.05.2024     
1757774  AMELGEN  pessary  400mg 30TK  Prescription           
1757785  AMELGEN  pessary  400mg 45TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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