Comirnaty Original/Omicron BA.4-5

Medicinal product

(Invented) name

Active substance (s)

COVID-19 mRNR vakcina. Tozinameranas/Famtozinameranas

Strength

1,5 µg/1,5 µg/dozėje

Pharmaceutical form

koncentratas injekcinei dispersijai

Route (s) of administration

leisti į raumenis

Purpose for use

6 mėn. kūdikiams - 4 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

One dose (0.2 mL) contains:	0.2 ml
COVID-19 mRNR vakcina. Tozinameranas	1,5 µg
Famtozinameranas	1,5 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
111382	97495	1097495	flakonas	N10 (daugiadozis, 100 dozių)		Receptinis	EU/1/20/1528/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2020-12-21	Registruotas