Comirnaty Omicron XBB.1.5

Medicinal product

(Invented) name

Comirnaty Omicron XBB.1.5

Active substance (s)

COVID-19 mRNR vakcina. Rakstozinameranas

Strength

30 µg/dozėje

Pharmaceutical form

injekcinė dispersija

Route (s) of administration

leisti į raumenis

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

Dispersion for injection. One dose (0,3 mL) contains:	0.3 ml
COVID-19 mRNR vakcina. Rakstozinameranas	30 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
111383	97496	1097496	flakonas	N10 (10 dozių)		Receptinis	EU/1/20/1528/018	Netiekiama	-	-	No	-	-
111384	97497	1097497	flakonas	N10 (daugiadozis, 60 dozių)		Receptinis	EU/1/20/1528/019	Netiekiama	-	-	No	-	-
111385	97498	1097498	flakonas	N195 (daugiadozis, 1170 dozių)		Receptinis	EU/1/20/1528/020	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-21	Registruotas