Spikevax JN.1

Medicinal product

(Invented) name

Spikevax JN.1

Active substance (s)

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

Strength

0,1 mg/ml

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

Flakone yra 2,5 ml	2.5 ml
COVID-19 iRNR vakcina. SARS-CoV-2 JN.1 iRNR	0,1 mg/ml

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
114915	101020	1101020	flakonas	N10 (daugiadozis, 50 arba 100 dozių) (stiklas)		Receptinis	EU/1/20/1507/019	Netiekiama	-	-	No	-	-
114916	101021	1101021	flakonas	N10 (daugiadozis, 50 arba 100 dozių) (ciklinis olefinų polimeras)		Receptinis	EU/1/20/1507/020	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-06	Registruotas