Spikevax bivalent Original/Omicron BA.1

Medicinal product

(Invented) name

Active substance (s)

COVID-19 iRNR vakcina (modifikuotais nukleozidais). Elasomeranas/Imelasomeranas

Strength

50 µg/50 µg/ml

Pharmaceutical form

injekcinė dispersija

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

Moderna Biotech Spain, S.L., Ispanija

Date of authorisation

2021-01-06

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

Dispersion for injection. 1 ml contains:	1 ml
COVID-19 iRNR vakcina (modifikuotais nukleozidais). Elasomeranas	50 µg
Imelasomeranas	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
109311	95417	1095417	flakonas	N10 (daugiadozis, 100 dozių)		Receptinis	EU/1/20/1507/004	Netiekiama	-	-	No	-	-
109312	95418	1095418	flakonas	N10 (daugiadozis, 50 dozių)		Receptinis	EU/1/20/1507/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-06	Registruotas