Ryeqo

Medicinal product

(Invented) name

Ryeqo

Active substance (s)

Relugoliksas/Estradiolis/Noretisterono acetatas

Strength

40 mg/1 mg/0,5 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)

H01CC54, relugolix, estradiol and norethisterone

Marketing authorisation holder

Gedeon Richter Plc, Vengrija

Date of authorisation

2021-07-16

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

Film-coated tablet	1 vnt.
Relugoliksas	40 mg
Estradiolis	1 mg
Noretisterono acetatas	0,5 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
106939	93042	1093042	buteliukas	N28		Receptinis	EU/1/21/1565/001	Tiekiama	-	-	No	-	-
108398	94502	1094502	buteliukas	N3×28		Receptinis	EU/1/21/1565/002	Netiekiama	-	-	No	-	-
112905	99023	1099023	lizdinė plokštelė	N28 (2×14)		Receptinis	EU/1/21/1565/003	Tiekiama	-	-	No	-	-
112906	99024	1099024	lizdinė plokštelė	N84 (6×14)		Receptinis	EU/1/21/1565/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-07-16	Registruotas