Bortezomib Krka

Medicinal product

(Invented) name

Bortezomib Krka

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

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

4315 Pakuotės lapelis 2021_04_29.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/5377/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	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
100724	86834	1086834	flakonas	N1		Receptinis	LT/1/18/4315/001	Netiekiama	-	-	No	-	-
100725	86835	1086835	flakonas	N5		Receptinis	LT/1/18/4315/002	Netiekiama	-	-	No	-	-
100726	86836	1086836	flakonas	N10		Receptinis	LT/1/18/4315/003	Netiekiama	-	-	No	-	-

Stadijos

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