Bendamustine medac

Medicinal product

(Invented) name

Bendamustine medac

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)

ATC code (s)

L01AA09, Bendamustine

Marketing authorisation holder

medac Gesellschaft für klinische Spezialpräparate mbH, Vokietija

Date of authorisation

2016-01-04

Date of renewal

2020-04-29

Documents

Stage

Perregistruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

DK/H/2416/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Po ištirpinimo 1 ml koncentrato yra:	1 ml
Bendamustino hidrochloridas	2,5 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
63271	77687	1077687	flakonas	25 mg N1	Receptinis	LT/1/16/3861/001	Tiekiama	-	-	No	-	-	Download
64689	79176	1079176	flakonas	25 mg N5	Receptinis	LT/1/16/3861/002	Netiekiama	-	-	No	-	-
64690	79177	1079177	flakonas	25 mg N10	Receptinis	LT/1/16/3861/003	Netiekiama	-	-	No	-	-
64691	79178	1079178	flakonas	100 mg N1	Receptinis	LT/1/16/3861/004	Tiekiama	-	-	No	-	-
64692	79179	1079179	flakonas	100 mg N5	Receptinis	LT/1/16/3861/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-04-29	Perregistruotas
2016-01-04	Registruotas