Comirnaty

Medicinal product

(Invented) name

Comirnaty

Active substance (s)

COVID-19 mRNR vakcina. Tozinameranas

Strength

30 µg/dozėje

Pharmaceutical form

injekcinė dispersija

Route (s) of administration

leisti į raumenis

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

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

One dose (0.3 mL) contains	0.3 ml
COVID-19 mRNR vakcina. Tozinameranas	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
107509	93614	1093614	flakonas	N10 (daugiadozis, 60 dozių)		Receptinis	EU/1/20/1528/002	Netiekiama	-	-	No	-	-
107510	93615	1093615	flakonas	N195 (daugiadozis) (1170 dozių)		Receptinis	EU/1/20/1528/003	Netiekiama	-	-	No	-	-
110004	96114	1096114	flakonas	N10 (10×1 dozę)		Receptinis	EU/1/20/1528/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2020-12-21	Registruotas