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

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
111906	98021	1098021	flakonas	N10 (daugiadozis, 50 dozių)		Receptinis	EU/1/21/1618/006	Netiekiama	-	-	No	-	-
111907	98022	1098022	flakonas	N2 (daugiadozis, 10 dozių)		Receptinis	EU/1/21/1618/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-20	Registruotas