Gedeon Richter

16 products tracked · names used in filings: Gedeon Richter, Gedeon Richter Ltd, Gedeon Richter Plc.

Upcoming milestones

Mon 23 Nov 2026🇪🇺 Expected EC decisionestimatein 9 days

Inijaq (tofacitinib): expected EC decision

Estimated as CHMP opinion (2026-09-17) + 67 days, the standard Commission decision period. Not an official date. · Gedeon Richter Plc. · source

Recent milestones

Thu 17 Sep 2026🇪🇺 CHMP positive opinion

Inijaq (tofacitinib): CHMP positive opinion

Gedeon Richter Plc.; Generic · source

Thu 26 Mar 2026🇪🇺 EU approval (EC decision)

Fylrevy (estetrol) approved in the EU

Marketing authorisation to Gedeon Richter Plc.; Additional monitoring · source

Thu 29 Jan 2026🇪🇺 CHMP positive opinion

Fylrevy (estetrol): CHMP positive opinion

Gedeon Richter Plc.; Additional monitoring · source

Products

ProductStatusApproved
🇪🇺Vivjoa
oteseconazole		Application withdrawn
🇪🇺Inijaq
tofacitinib		Opinion
🇪🇺Efgratin
pegfilgrastim		Application withdrawn
🇪🇺Efgratin
pegfilgrastim		Application withdrawn
🇪🇺Fylrevy
estetrol		Authorised2026-03-26
🇪🇺Usymro
ustekinumab		Authorised2025-08-14
🇪🇺Yaxwer
denosumab		Authorised2025-06-23
🇪🇺Junod
denosumab		Authorised2025-06-23
🇪🇺Ryeqo
relugolix;estradiol;norethisterone acetate		Authorised2021-07-16
🇪🇺Drovelis
estetrol;drospirenone		Authorised2021-05-19
🇪🇺Ulipristal Acetate Gedeon Richter
ulipristal acetate		Withdrawn2018-08-27
🇪🇺Reagila
cariprazine		Authorised2017-07-13
🇪🇺Terrosa
teriparatide		Authorised2017-01-04
🇪🇺Bemfola
follitropin alfa		Authorised2014-03-26
🇪🇺Esmya
ulipristal		Withdrawn2012-02-22
🇪🇺Evra
norelgestromin;ethinyl estradiol		Authorised2002-08-22

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.