Vevzuo

Medicinal product

(Invented) name

Vevzuo

Active substance (s)

Denozumabas

Strength

120 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

M05BX04, Denosumab

Marketing authorisation holder

Biosimilar Collaborations Ireland Limited, Airija

Date of authorisation

2025-06-25

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(4)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Flakone (1,7 ml tirpalo) yra	1.7 ml
Denozumabas	120 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
117908	104013	1104013	flakonas	1,7 ml N1		Receptinis	EU/1/25/1945/001	Netiekiama	-	-	No	-	-
118366	104472	1104472	flakonas	1,7 ml N3		Receptinis	EU/1/25/1945/002	Netiekiama	-	-	No	-	-
118367	104473	1104473	flakonas	1,7 ml N4		Receptinis	EU/1/25/1945/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-25	Registruotas