Nuvaxovid XFG

Medicinal product

(Invented) name

Nuvaxovid XFG

Active substance (s)

SARS-CoV-2 (Omicron XFG) rekombinantinio spyglio baltymas su adjuvantu Matrix-M

Strength

5 µg/dozėje

Pharmaceutical form

injekcinė dispersija užpildytame švirkšte

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

Sanofi Winthrop Industrie, Prancūzija

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
SARS-CoV-2 (Omicron XFG) rekombinantinio 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
121785	107894	1107894	užpildytas švirkštas	N10 (10 dozių)	Receptinis	EU/1/21/1618/014	Netiekiama	-	-	No	-	-
121786	107895	1107895	užpildytas švirkštas	N1 (1 dozė)	Receptinis	EU/1/21/1618/015	Netiekiama	-	-	No	-	-
121787	107896	1107896	užpildytas švirkštas	N1 (1 dozė, su adata)	Receptinis	EU/1/21/1618/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-12-20	Registruotas