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

2018-10-08

Date of renewal

Documents

4275_1_6 Pakuotės lapelis 201224.docx

4275_1_6 Bendamustine Sandoz PCS PL 201224.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2794/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Paruoštame koncentrate 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
100248	86357	1086357	flakonas	25 mg N1		Receptinis	LT/1/18/4275/001	Netiekiama	-	-	No	-	-
100249	86358	1086358	flakonas	25 mg N5		Receptinis	LT/1/18/4275/002	Netiekiama	-	-	No	-	-
100250	86359	1086359	flakonas	25 mg N10		Receptinis	LT/1/18/4275/003	Netiekiama	-	-	No	-	-
100251	86360	1086360	flakonas	25 mg N20		Receptinis	LT/1/18/4275/004	Netiekiama	-	-	No	-	-
100252	86361	1086361	flakonas	100 mg N1		Receptinis	LT/1/18/4275/005	Netiekiama	-	-	No	-	-
100253	86362	1086362	flakonas	100 mg N5		Receptinis	LT/1/18/4275/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-11-29	Išregistruotas
2018-10-08	Registruotas