SonoVue

Medicinal product

(Invented) name

SonoVue

Active substance (s)

Sieros heksafluorido mikroburbuliukai

Strength

8 µl/ml

Pharmaceutical form

milteliai ir tirpiklis injekcinei dispersijai

Route (s) of administration

leisti į veną, vartoti į šlapimo pūslę

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

V08DA04, Perflutren, human albumin microspheres

Marketing authorisation holder

Bracco International B.V., Italija

Date of authorisation

2001-03-26

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

Powder and solvent for dispersion for injection	1 ml
Sieros heksafluorido mikroburbuliukai	8 µl

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
28297	30827	1030827	flakonas	milteliai, tirpiklio užpildytas švirkštas (5 ml) ir perdavimo sistema MiniSpike N1		Receptinis	EU/1/01/177/002	Tiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2001-03-26	Registruotas