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 užpildytame švirkšte

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

1 dozė. 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	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
115226	101335	1101335	užpildytas švirkštas	N10 (10 dozių) (tik atšaldyti)		Receptinis	EU/1/20/1528/039	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-21	Registruotas