Spikevax JN.1

Medicinal product

(Invented) name

Spikevax JN.1

Active substance (s)

COVID-19 iRNR vakcina. SARS-CoV-2 JN.1 iRNR

Strength

50 µg

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

Moderna Biotech Spain, S.L., Ispanija

Date of authorisation

2021-01-06

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

Vienoje dozėje (0,5 ml) yra	0.5 ml
COVID-19 iRNR vakcina. SARS-CoV-2 JN.1 iRNR	50 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
114917	101022	1101022	flakonas	0,5 ml N1 (1 dozė)		Receptinis	EU/1/20/1507/021	Netiekiama	-	-	No	-	-
114918	101023	1101023	flakonas	0,5 ml N10 (10 dozių)		Receptinis	EU/1/20/1507/022	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-06	Registruotas