COVID-19 Vaccine (inactivated, adjuvanted) Valneva

Medicinal product

(Invented) name

Active substance (s)

COVID-19 vakcina (inaktyvinta, su adjuvantu, adsorbuota) (SARS-CoV-2 virusas)

Strength

33 AgV/dozėje

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BX03, Covid-19 vaccines

Marketing authorisation holder

Valneva Austria GmbH, Austrija

Date of authorisation

2022-06-24

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection. One dose (0.5 mL) contains:	0.5 ml
COVID-19 vakcina (inaktyvinta, su adjuvantu, adsorbuota) (SARS-CoV-2 virusas)	33 AgV

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
108562	94666	1094666	flakonas	10 dozių × 0,5 ml N10 (100 dozių)		Receptinis	EU/1/21/1624/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-01	Išregistruotas
2022-06-24	Registruotas