Bortezomib Ebewe

Medicinal product

(Invented) name

Bortezomib Ebewe

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

2017-01-26

Date of renewal

Documents

4032_1_4 Pakuotės lapelis 190314.docx

4032_1_4 Bortezomib Ebewe milt inj PCS PL 190314.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/3701/001/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
65008	79503	1079503	flakonas	N1		Receptinis	LT/1/17/4032/001	Netiekiama	-	-	No	-	-	Download
67481	82034	1082034	flakonas	N3		Receptinis	LT/1/17/4032/002	Netiekiama	-	-	No	-	-
67482	82035	1082035	flakonas	N5		Receptinis	LT/1/17/4032/003	Netiekiama	-	-	No	-	-
67483	82036	1082036	flakonas	N10		Receptinis	LT/1/17/4032/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-11-05	Išregistruotas
2017-01-26	Registruotas