Nuvaxovid JN.1

Medicinal product

(Invented) name

Nuvaxovid JN.1

Active substance (s)

COVID-19 vakcina (rekombinantinė, adjuvantinė). SARS-CoV-2 (Omicron JN.1) spyglio baltymas su adjuvantu Matrix-M

Strength

5 µg/dozėje

Pharmaceutical form

injekcinė dispersija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BN04, covid-19, protein subunit

Marketing authorisation holder

Novavax CZ a.s., Čekija

Date of authorisation

2021-12-20

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Dozėje (0,5 ml) yra:	0.5 ml
COVID-19 vakcina (rekombinantinė, adjuvantinė). SARS-CoV-2 (Omicron JN.1) spyglio baltymas su adjuvantu Matrix-M	5 µg

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
115478	101584	1101584	flakonas	N10 (10 dozių)		Receptinis	EU/1/21/1618/007	Nepradėtas tiekti	-	-	No	-	-
115479	101585	1101585	flakonas	N1 (1 dozė)		Receptinis	EU/1/21/1618/009	Nepradėtas tiekti	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-20	Registruotas