Bendamustine Kabi

Medicinal product

(Invented) name

Bendamustine Kabi

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

Fresenius Kabi Polska Sp.z.o.o., Lenkija

Date of authorisation

2017-01-03

Date of renewal

2022-05-18

Documents

4023 Bendamustine Kabi PCS PL 2024 05 23.docx

4023 Pakuotės lapelis 2024 05 23.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0587/001/E/001

Marketing authorisation procedure

Kartotinė procedūra

Qualitative and quantitative composition

Po ištirpinimo 1 ml tirpalo 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
67334	81884	1081884	flakonas	25 mg N1		Receptinis	LT/1/17/4023/001	Netiekiama	-	-	No	-	-	Download
67335	81885	1081885	flakonas	25 mg N5		Receptinis	LT/1/17/4023/002	Netiekiama	-	-	No	-	-
67336	81886	1081886	flakonas	25 mg N10		Receptinis	LT/1/17/4023/003	Netiekiama	-	-	No	-	-
67337	81887	1081887	flakonas	25 mg N20		Receptinis	LT/1/17/4023/004	Netiekiama	-	-	No	-	-
67338	81888	1081888	flakonas	100 mg N1		Receptinis	LT/1/17/4023/005	Tiekiama	-	-	No	-	-	Download
67339	81889	1081889	flakonas	100 mg N5		Receptinis	LT/1/17/4023/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-05-18	Perregistruotas
2017-01-03	Registruotas