Comirnaty KP.2

Medicinal product

(Invented) name

Comirnaty KP.2

Active substance (s)

COVID-19 RNR vakcina (modifikuotais nukleozidais, įterpta į lipidines nanodaleles). Cemivameranas

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)

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

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Dozėje (0,3 ml ) yra	0.3 ml
COVID-19 mRNR vakcina (modifikuotais nukleozidais, įterpta į lipidines nanodaleles). Cemivameranas	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
115228	101337	1101337	flakonas	N10 (10 dozių)		Receptinis	EU/1/20/1528/040	Netiekiama	-	-	No	-	-
115229	101338	1101338	flakonas	N10 (60 dozių)		Receptinis	EU/1/20/1528/041	Tiekiama	2025-07-07	-	No	-	-

Stadijos

Data	Stadija
2020-12-21	Registruotas