Bendamustine Accord

Medicinal product

(Invented) name

Bendamustine Accord

Active substance (s)

Bendamustino hidrochloridas

Strength

25 mg/ml

Pharmaceutical form

koncentratas infuziniam tirpalui

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

2022-04-15

Date of renewal

Documents

4943 Pakuotės lapelis 2024 06 14.docx

4943 Bendamustine Accord konc PCS PL 2024 06 14.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(3)

Procedure number

AT/H/0497/002DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

1 ml tirpalo yra:	1 ml
Bendamustino hidrochloridas	25 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
108500	94604	1094604	flakonas	4 ml N1		Receptinis	LT/1/22/4943/001	Netiekiama	-	-	No	-	-
108501	94605	1094605	flakonas	4 ml N5		Receptinis	LT/1/22/4943/002	Netiekiama	2025-07-09	2025-09-30	No	-	-
112050	98165	1098165	flakonas	1 ml N1		Receptinis	LT/1/22/4943/003	Netiekiama	-	-	No	-	-
112051	98166	1098166	flakonas	1 ml N5		Receptinis	LT/1/22/4943/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-04-15	Registruotas