XGEVA

Medicinal product

(Invented) name

XGEVA

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

Amgen Europe B.V., Nyderlandai

Date of authorisation

2011-07-13

Date of renewal

Documents

Xgeva paciento kortele.pdf

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Solution for injection	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
47983	61806	1061806	flakonas	1,7 ml N1		Receptinis	EU/1/11/703/001	Tiekiama	-	-	No	-	-
47984	61807	1061807	flakonas	1,7 ml N4		Receptinis	EU/1/11/703/002	Netiekiama	-	-	No	-	-
51721	65618	1065618	flakonas	1,7 ml N3		Receptinis	EU/1/11/703/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-07-13	Registruotas