Spikevax

Medicinal product

(Invented) name

Spikevax

Active substance (s)

COVID-19 iRNR vakcina (modifikuotais nukleozidais). Elasomeranas

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)

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. One dose (0.5 mL) contains:	0.5 ml
COVID-19 iRNR vakcina (modifikuotais nukleozidais). Elasomeranas	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
109263	95369	1095369	flakonas	N10 (daugiadozis, 50 dozių)		Receptinis	EU/1/20/1507/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-06	Registruotas