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

30 µg/dozėje

Pharmaceutical form

injekcinė dispersija

Route (s) of administration

leisti į raumenis

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	30 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
114224	100336	1100336	flakonas	N10 (10 dozių)	Receptinis	EU/1/20/1528/037	Netiekiama	-	-	No	-	-
115225	101334	1101334	flakonas	N10 (60 dozių)	Receptinis	EU/1/20/1528/038	Netiekiama	-	-	No	-	-
117793	103897	1103897	flakonas	N10 (60 dozių) (tik atšaldyti)	Receptinis	EU/1/20/1528/044	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-21	Registruotas