Xbryk

Medicinal product

(Invented) name

Xbryk

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

Samsung Bioepis NL B.V., Nyderlandai

Date of authorisation

2025-02-12

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) injekcinio 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
116615	102714	1102714	flakonas	N1		Receptinis	EU/1/24/1889/001	Netiekiama	-	-	No	-	-
116616	102715	1102715	flakonas	N3		Receptinis	EU/1/24/1889/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-02-12	Registruotas