Comirnaty Original/Omicron BA.4-5

Medicinal product

(Invented) name

Active substance (s)

COVID-19 mRNR vakcina. Tozinameranas/Famtozinameranas

Strength

5 µg/5 µg/dozėje

Pharmaceutical form

injekcinė dispersija

Route (s) of administration

leisti į raumenis

Purpose for use

5-11 m. vaikams

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	5 µg
Famtozinameranas	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
111380	97493	1097493	flakonas	N10 (vienadoziai, 10 dozių)		Receptinis	EU/1/20/1528/015	Netiekiama	-	-	No	-	-
111381	97494	1097494	flakonas	N10 (daugiadozis, 60 dozių)		Receptinis	EU/1/20/1528/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2020-12-21	Registruotas