Bendamustine Hydrochloride Boston Biopharma

Medicinal product

(Invented) name

Bendamustine Hydrochloride Boston Biopharma

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

UAB Boston Biopharma LT , Lietuva

Date of authorisation

2022-08-01

Date of renewal

Documents

4995_Bendamustine_HCl_Boston_Biopharma.docx

4995_pakuotes lapelis_2022-08-01.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0219/001/DC

Marketing authorisation procedure

Decentralizuota 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	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
109073	95179	1095179	flakonas	25 mg N1		Receptinis	LT/1/22/4995/001	Netiekiama	-	-	No	-	-
109074	95180	1095180	flakonas	100 mg N1		Receptinis	LT/1/22/4995/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-03-28	Išregistruotas
2022-08-01	Registruotas