Bortezomib Krka

Medicinal product

(Invented) name

Bortezomib Krka

Active substance (s)

Bortezomibas

Strength

1 mg

Pharmaceutical form

milteliai injekciniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01XG01, bortezomib

Marketing authorisation holder

KRKA, d.d., Novo mesto, Slovėnija

Date of authorisation

2018-12-28

Date of renewal

Documents

4314_4315 Bortezomib Krka milt inj PCS 2022 02 01.docx

4314 Pakuotės lapelis 2021_04_29.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/5377/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Bortezomibas	1 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
100721	86831	1086831	flakonas	N1		Receptinis	LT/1/18/4314/001	Netiekiama	-	-	No	-	-
100722	86832	1086832	flakonas	N5		Receptinis	LT/1/18/4314/002	Netiekiama	-	-	No	-	-
100723	86833	1086833	flakonas	N10		Receptinis	LT/1/18/4314/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-06-30	Išregistruotas
2018-12-28	Registruotas