Bortezomib Sandoz

Medicinal product

(Invented) name

Bortezomib Sandoz

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)

L01XX32, Bortezomib

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2015-12-10

Date of renewal

Documents

3849_1-4 Bortezomib_Sandoz_DP.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3154/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kiekviename 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
59136	73358	1073358	flakonas	N1		Receptinis	LT/1/15/3849/001	Netiekiama	-	-	No	-	-
64439	78923	1078923	flakonas	N3		Receptinis	LT/1/15/3849/002	Netiekiama	-	-	No	-	-
64440	78924	1078924	flakonas	N5		Receptinis	LT/1/15/3849/003	Netiekiama	-	-	No	-	-
64441	78925	1078925	flakonas	N10		Receptinis	LT/1/15/3849/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-03-09	Išregistruotas
2015-12-10	Registruotas