Bendamustine Accord

Medicinal product

(Invented) name

Bendamustine Accord

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

Accord Healthcare B.V., Nyderlandai

Date of authorisation

2015-12-10

Date of renewal

2020-10-23

Documents

3848 Pakuotės lapelis 2024 06 14.docx

3848 Bendamustine Accord milt PCS PL 2024 06 14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

AT/H/0497/001/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
63270	77686	1077686	flakonas	25 mg N5		Receptinis	LT/1/15/3848/001	Netiekiama	-	-	No	-	-
64435	78919	1078919	flakonas	25 mg N10		Receptinis	LT/1/15/3848/002	Netiekiama	-	-	No	-	-
64436	78920	1078920	flakonas	25 mg N20		Receptinis	LT/1/15/3848/003	Netiekiama	-	-	No	-	-
64437	78921	1078921	flakonas	100 mg N1		Receptinis	LT/1/15/3848/004	Netiekiama	-	-	No	-	-
64438	78922	1078922	flakonas	100 mg N5		Receptinis	LT/1/15/3848/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-10-23	Perregistruotas
2015-12-10	Registruotas