JEMPERLI

Medicinal product

(Invented) name

JEMPERLI

Active substance (s)

Dostarlimabas

Strength

500 mg

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)

L01FF07, dostarlimab

Marketing authorisation holder

GlaxoSmithKline (Ireland) Limited , Airija

Date of authorisation

2021-04-21

Date of renewal

Documents

Jemperli paciento kortele.pdf

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	10 ml
Dostarlimabas	500 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
106381	92482	1092482	flakonas	10 ml N1		Receptinis	EU/1/21/1538/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-21	Registruotas