Comirnaty Original/Omicron BA.1

Medicinal product

(Invented) name

Active substance (s)

COVID-19 mRNR vakcina. Tozinameranas/Riltozinameranas

Strength

15 µg/15 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)

J07BN01, covid-19, RNA-based vaccine

Marketing authorisation holder

BioNTech Manufacturing GmbH, Vokietija

Date of authorisation

2020-12-21

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

Dispersion for injection. One dose (0,3 mL) contains:	0.3 ml
COVID-19 mRNR vakcina. Tozinameranas	15 µg
Riltozinameranas	15 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
109261	95367	1095367	flakonas	N10 (daugiadozis, 60 dozių)		Receptinis	EU/1/20/1528/006	Netiekiama	-	-	No	-	-
109262	95368	1095368	flakonas	N195 (daugiadozis, 1170 dozių)		Receptinis	EU/1/20/1528/007	Netiekiama	-	-	No	-	-

Stadijos