XGEVA

Medicinal product

(Invented) name

XGEVA

Active substance (s)

Denozumabas

Strength

120 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

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

1 ml tirpalo yra:	1 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
113542	99660	1099660	užpildytas švirkštas	1 ml N1 (su automatine adatos apsauga)		Receptinis	EU/1/11/703/004	Netiekiama	-	-	No	-	-
113543	99661	1099661	užpildytas švirkštas	1 ml N3 (su automatine adatos apsauga)		Receptinis	EU/1/11/703/005	Netiekiama	-	-	No	-	-
113544	99662	1099662	užpildytas švirkštas	1 ml N4 (su automatine adatos apsauga)		Receptinis	EU/1/11/703/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2011-07-13	Registruotas