Orgovyx

Medicinal product

(Invented) name

Orgovyx

Active substance (s)

Relugoliksas

Strength

120 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)

L02BX04, relugolix

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2022-04-29

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.
Relugoliksas	120 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
108563	94667	1094667	buteliukas	N30		Receptinis	EU/1/22/1642/001	Tiekiama	-	-	No	-	-
110803	96914	1096914	buteliukas	N90 (3×30)		Receptinis	EU/1/22/1642/002	Netiekiama	-	-	No	-	-
117789	103893	1103893	lizdinė plokštelė	N30		Receptinis	EU/1/22/1642/003	Netiekiama	-	-	No	-	-
117790	103894	1103894	lizdinė plokštelė	N90		Receptinis	EU/1/22/1642/004	Netiekiama	-	-	No	-	-
117791	103895	1103895	buteliukas	N90		Receptinis	EU/1/22/1642/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-29	Registruotas