Onbevzi

Medicinal product

(Invented) name

Onbevzi

Active substance (s)

Bevacizumabas

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)

L01FG01, Bevacizumab

Marketing authorisation holder

Samsung Bioepis NL B.V., Nyderlandai

Date of authorisation

2021-01-11

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Concentrate for solution for infusion	1 ml
Bevacizumabas	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
105651	91751	1091751	flakonas	4 ml N1		Receptinis	EU/1/20/1499/001	Netiekiama	-	-	No	-	-
105652	91752	1091752	flakonas	16 ml N1		Receptinis	EU/1/20/1499/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-11	Išregistruotas
2021-01-11	Registruotas