IMFINZI

Medicinal product

(Invented) name

IMFINZI

Active substance (s)

Durvalumabas

Strength

50 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FF03, durvalumab

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2018-09-21

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

Concentrate for solution for infusion	1 ml
Durvalumabas	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
100313	86422	1086422	flakonas	10 ml N1		Receptinis	EU/1/18/1322/001	Tiekiama	-	-	No	-	-
100314	86423	1086423	flakonas	2,4 ml N1		Receptinis	EU/1/18/1322/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-09-21	Registruotas