Bendamustina Hikma

Medicinal product

(Invented) name

Bendamustina Hikma

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 Edupharma, Lietuva

Date of authorisation

2024-02-19

Date of renewal

Documents

2077_Bendamustina_Hikma_2,5mg_PIL_2024-02-19.docx

2077_Bendamustina_Hikma_2,5mg_PZ_2024-02-19.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

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
112961	99079	1099079	flakonas	25 mg N5	ASPĮ	Receptinis	LT/L/24/2077/001	Netiekiama	-	-	No	-	-	Download
112962	99080	1099080	flakonas	100 mg N5	ASPĮ	Receptinis	LT/L/24/2077/002	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2024-02-19	Registruotas