Comirnaty Omicron XBB.1.5

Medicinal product

(Invented) name

Comirnaty Omicron XBB.1.5

Active substance (s)

COVID-19 mRNR vakcina. Rakstozinameranas

Strength

10 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)

No

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

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

One dose (0.3 mL) contains:	0.3 ml
COVID-19 mRNR vakcina. Rakstozinameranas	10 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
111386	97499	1097499	flakonas	N10 (10 dozių)		Receptinis	EU/1/20/1528/022	Netiekiama	-	-	No	-	-
111387	97500	1097500	flakonas	N10 (daugiadozis, 60 dozių)		Receptinis	EU/1/20/1528/023	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-21	Registruotas