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 užpildytame švirkšte

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

Užpildytame švirkšte yra 1 dozė (0,3 mL)	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
113716	99835	1099835	užpildytas švirkštas	N10 (10 dozių) (plastikinis)		Receptinis	EU/1/20/1528/025	Netiekiama	-	-	No	-	-
114207	100319	1100319	užpildytas švirkštas	N10 (10 dozių) (stiklinis)		Receptinis	EU/1/20/1528/027	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-21	Registruotas