Register of Medicinal Products

AMELGEN

Product class:	Medicinal product with marketing authorization
Medicinal product class:	Human medicine
Name of medicinal product:	AMELGEN
Active substances:	Progesterone 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

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)

Packages approved by this marketing authorization

Package code	Name of medicinal product	Dosage form	Package	Legal status	Reimbursements	Reference price	Last imported	PĆ¤ritolumaa	Additional information
1708556	AMELGEN	pessary	400mg 12TK	Prescription
1708567	AMELGEN	pessary	400mg 15TK	Prescription			20.09.2023
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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