Xofigo

Medicinal product

(Invented) name

Xofigo

Active substance (s)

Radžio Ra 223 dichloridas

Strength

1100 kBq/ml

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V10XX03, Radium (223Ra) dichloride

Marketing authorisation holder

Bayer AG, Vokietija

Date of authorisation

2013-11-13

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

Solution for injection	1 ml
Radžio Ra 223 dichloridas	1100 kBq

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
57945	72067	1072067	flakonas	6 ml N1		Receptinis	EU/1/13/873/001	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-11-13	Registruotas