Bortezomib SUN

Medicinal product

(Invented) name

Bortezomib SUN

Active substance (s)

Bortezomibas

Strength

3,5 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti į veną, leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XG01, bortezomib

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B. V., Nyderlandai

Date of authorisation

2016-07-22

Date of renewal

Documents

Bortezomib SUN mokomoji medžiaga sveikatos priežiūros specialistams.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder for solution for injection	1 vnt.
Bortezomibas	3,5 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
66233	80755	1080755	flakonas	N1		Receptinis	EU/1/16/1102/001	Tiekiama	2025-01-01	-	No	-	-

Stadijos

Data	Stadija
2016-07-22	Registruotas