Nuvaxovid

Medicinal product

(Invented) name

Nuvaxovid

Active substance (s)

COVID-19 vakcina (rekombinantinė, adjuvantinė) (SARS-CoV-2 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

One dose (0.5 mL) contains:	0.5 ml
COVID-19 vakcina (rekombinantinė, adjuvantinė) (SARS-CoV-2 spyglio baltymas su adjuvantu Matrix-M)	5 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
107781	93886	1093886	flakonas	N10 (daugiadozis, 100 dozių)	Receptinis	EU/1/21/1618/001	Netiekiama	-	-	No	-	-
110723	96834	1096834	flakonas	N10 (daugiadozis, 50 dozių)	Receptinis	EU/1/21/1618/002	Netiekiama	-	-	No	-	-
111192	97303	1097303	flakonas	N2 (daugiadozis, 20 dozių)	Receptinis	EU/1/21/1618/003	Netiekiama	-	-	No	-	-
111193	97304	1097304	flakonas	N2 (daugiadozis, 10 dozių)	Receptinis	EU/1/21/1618/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-20	Registruotas