SAI - Detailed view

SONOVUE Trockensub c Solv Inj kit

Drug

Name

SonoVue 8 µL/mL, polvere e solvente per dispersione iniettabile

ATC

V08DA05 - SULFUR HEXAFLUORIDE, PHOSPHOLIPID MICROSPHERES

14.03.0. – other diagnostics

Use

HAM – Human medicine

pharmaceutical form

PULMD – Powder and solvent for dispersion for injection

Remedy code

S – synthetic products for human use

Dispensing categories

B – Dispensed on prescription by a physician or veterinarian (B)

Authorisation status

Z – approved

Authorisation number

56032

Initial registration date

8/7/2002

Expiry date

12/31/9999

Dosage strength

Name

SonoVue 8 µL/mL, polvere e solvente per dispersione iniettabile

Field of application

Mezzo di contrasto per l'ultrasonografia

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680560320010

Trade status*

In trade from / since 8/7/2002

Status

A/R – Authorised / referenced

Package size

1 bottle(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component Freeze-dried preparation

Active substance

225 µg sulfuris hexafluoridum

Excipient

macrogolum 4000
1,2-distearoyl-sn-glycero-3-phosphocholinum
1,2-dipalmitoyl-sn-glycero-3-phospho-rac-glycerolum natricum
acidum palmiticum

Component Solvent

Excipient

natrii chloridum
aqua ad iniectabile

Component Reconstituted solution

Active substance

8 µl sulfuris hexafluoridum

Excipient

45 µg sulfuris hexafluoridum
3.542 mg natrium

Spezialitätenliste***

Status

Date of deletion

Compulsory until

Public price (CHF)

101.25

Limitation points

None

Limitation

SB Deductible

10%

Generic

Authorisation holder

GLN**

7601001368750

Address

Bracco Suisse SA
Via Ponteggia 23
6814 Cadempino (TI)

Date of revision of the text

4/29/2025

Information for prof.

Leaflet

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Data source: Swissmedic, *authorisation holder, **Refdata foundation, ***FOPH.