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

3 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

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	3 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
115227	101336	1101336	flakonas	N10 (30 dozių)		Receptinis	EU/1/20/1528/042	Tiekiama	2025-07-07	-	No	-	-

Stadijos

Data	Stadija
2020-12-21	Registruotas