Quadramet

Medicinal product

(Invented) name

Quadramet

Active substance (s)

Samario [153Sm] leksidronamo natrio druska

Strength

1,3 GBq/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)

V10BX02, Samarium (153Sm) lexidronam

Marketing authorisation holder

CIS bio International, Prancūzija

Date of authorisation

1998-02-05

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
Samario [153Sm] leksidronamo natrio druska	1,3 GBq

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
28017	30554	1030554	flakonas	1,5 ml (2 GBq) - 3,1 ml (4 GBq) N1		Receptinis	EU/1/97/057/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
1998-02-05	Registruotas