SAI - Detailed view

Nuvaxovid 0.5 ml, Injektionsdispersion 10 x 5 ml

Drug

Name

Nuvaxovid, Injektionsdispersion

Field of application

Aktive Immunisierung zur Vorbeugung der durch das SARS-CoV-2-Virus verursachten Coronavirus-2019-Erkrankung (COVID-19) ab 12 Jahren

ATC

J07BX03 - COVID-19 VACCINES

08.08. – vaccines

Use

HAM – Human medicine

pharmaceutical form

DISIJ – dispersion for injection

Remedy code

I – vaccines

Dispensing categories

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

Authorisation status

D – no longer approved

Authorisation number

68473

Initial registration date

4/12/2022

Expiry date

3/21/2024

Dosage strength

Name

Nuvaxovid 0.5 ml, Injektionsdispersion

Field of application

Aktive Immunisierung zur Vorbeugung der durch das SARS-CoV-2-Virus verursachten Coronavirus-2019-Erkrankung (COVID-19) ab 12 Jahren

Dosage strength number

Authorisation status

D – no longer approved

Package

Trade status*

Out of trade from / since 3/21/2024

Status

NA – No longer authorised

Package size

10 x 5 ml vial(s)

Package code

001

Authorisation status

D – no longer approved

Declaration

Component

Active substance

5 µg SARS CoV-2 rS NVX-CoV2373

Excipient

42.5 µg saponinum
7.5 µg saponinum
Quillaja saponariae Molina extractum purificatum
cholesterolum
phosphatidylcholinum
int-rac-alpha-tocopherolum
kalii dihydrogenophosphas
kalii chloridum
dinatrii phosphas dihydricus
dinatrii phosphas heptahydricus
natrii dihydrogenophosphas monohydricus
natrii chloridum
polysorbatum 80
natrii hydroxidum
acidum hydrochloridum
aqua ad iniectabile
4.0 mg natrium
0.003 mg kalium

Authorisation holder

GLN**

7601001397088

Address

Future Health Pharma GmbH
Guyer-Zeller-Strasse 10
8620 Wetzikon ZH (ZH)

Date of revision of the text

5/1/2025

Information for prof.

Leaflet

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