Comirnaty LP.8.1

Medicinal product

(Invented) name

Comirnaty LP.8.1

Active substance (s)

COVID-19 mRNR vakcina (mRNR, kuri koduoja LP.8.1)

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)

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

Dozėje yra	0.3 ml
COVID-19 mRNR vakcina (mRNR, kuri koduoja LP.8.1)	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
118384	104490	1104490	flakonas	N10 (10 dozių)		Receptinis	EU/1/20/1528/048	Netiekiama	-	-	No	-	-
118385	104491	1104491	flakonas	N10 (60 dozių)		Receptinis	EU/1/20/1528/049	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-12-21	Registruotas