Evrenzo

Medicinal product

(Invented) name

Evrenzo

Active substance (s)

Roksadustatas

Strength

50 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)

B03XA05, Roxadustat

Marketing authorisation holder

Astellas Pharma Europe B.V., Nyderlandai

Date of authorisation

2021-08-18

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.
Roksadustatas	50 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
107131	93234	1093234	dalomoji lizdinė plokštelė	N12×1		Receptinis	EU/1/21/1574/002	Netiekiama	-	-	No	-	-
111119	97230	1097230	dalomoji lizdinė plokštelė	N36×1		Receptinis	EU/1/21/1574/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-08-18	Registruotas