Spikevax XBB.1.5

Medicinal product

(Invented) name

Spikevax XBB.1.5

Active substance (s)

COVID-19 iRNR vakcina (modifikuotais nukleozidais). Andusomeranas

Strength

50 µg

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). Andusomeranas	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
111726	97841	1097841	flakonas	N1 (1 dozė)		Receptinis	EU/1/20/1507/013	Netiekiama	-	-	No	-	-
111727	97842	1097842	flakonas	N10 (10 dozių)		Receptinis	EU/1/20/1507/014	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-06	Registruotas