Nuvaxovid XBB 1.5

Medicinal product

(Invented) name

Nuvaxovid XBB 1.5

Active substance (s)

COVID-19 vakcina (rekombinantinė, adjuvantinė) (SARS-CoV-2 (Omicron XBB.1.5) 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

Vienadozis. Kiekvienoje dozėje (0,5 ml) yra	0.5 ml
COVID-19 vakcina (rekombinantinė, adjuvantinė) (SARS-CoV-2 (Omicron XBB.1.5) 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
115204	101313	1101313	flakonas	N10 (10 dozių)		Receptinis	EU/1/21/1618/005	Netiekiama	-	-	No	-	-
115205	101314	1101314	flakonas	N1 (1 dozė)		Receptinis	EU/1/21/1618/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-20	Registruotas