Bendamustine Sandoz

Medicinal product

(Invented) name

Bendamustine Sandoz

Active substance (s)

Bendamustino hidrochloridas

Strength

2,5 mg/ml

Pharmaceutical form

milteliai infuzinio tirpalo koncentratui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01AA09, Bendamustine

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2016-01-04

Date of renewal

Documents

3862_1_6 Bendamustine Sandoz RPP 170428.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2344/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Viename paruošto tirpalo mililitre yra	1 ml
Bendamustino hidrochloridas	2,5 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
63201	77616	1077616	flakonas	25 mg N1		Receptinis	LT/1/16/3862/001	Netiekiama	-	-	No	-	-
64693	79180	1079180	flakonas	25 mg N5		Receptinis	LT/1/16/3862/002	Netiekiama	-	-	No	-	-
64694	79181	1079181	flakonas	25 mg N10		Receptinis	LT/1/16/3862/003	Netiekiama	-	-	No	-	-
64695	79182	1079182	flakonas	25 mg N20		Receptinis	LT/1/16/3862/004	Netiekiama	-	-	No	-	-
64696	79183	1079183	flakonas	100 mg N1		Receptinis	LT/1/16/3862/005	Netiekiama	-	-	No	-	-
64697	79184	1079184	flakonas	100 mg N5		Receptinis	LT/1/16/3862/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2018-02-07	Išregistruotas
2016-01-04	Registruotas