Blincyto

Medicinal product

(Invented) name

Blincyto

Active substance (s)

Blinatumomabas

Strength

38,5 µg

Pharmaceutical form

milteliai koncentratui ir tirpalas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01FX07, Blinatumomab

Marketing authorisation holder

Amgen Europe B.V., Nyderlandai

Date of authorisation

2015-11-23

Date of renewal

Documents

Blincyto mokomoji medziaga pacientams_globejams.pdf

Blincyto paciento kortele.pdf

Blincyto mokomoji medziaga slaugytojams.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

Powder for concentrate and solution for solution for infusion	1 vnt.
Blinatumomabas	38,5 µg

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
64385	78868	1078868	flakonas	milteliai, tirpalo flakonas (10 ml) N1		Receptinis	EU/1/15/1047/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2015-11-23	Registruotas