FYLREVY

Medicinal product

(Invented) name

FYLREVY

Active substance (s)

Estetrolis

Strength

18,9 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

G03CA10, estetrol

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2026-03-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Tabletėje yra:	1 vnt.
Estetrolis	18,9 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
120529	106633	1106633	lizdinė plokštelė	N28		Receptinis	EU/1/26/2020/004	Netiekiama	-	-	No	-	-
120530	106634	1106634	lizdinė plokštelė	N84		Receptinis	EU/1/26/2020/005	Netiekiama	-	-	No	-	-
120531	106635	1106635	lizdinė plokštelė	N168		Receptinis	EU/1/26/2020/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-03-26	Registruotas