Spikevax XBB.1.5

Medicinal product

(Invented) name

Spikevax XBB.1.5

Active substance (s)

COVID-19 iRNR vakcina (modifikuotais nukleozidais). Andusomeranas

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	1 ml
COVID-19 iRNR vakcina (modifikuotais nukleozidais). Andusomeranas	0,1 mg

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
111724	97838	1097838	flakonas	N10 (daugiadozis, 50 arba 100 dozių) (stiklas)		Receptinis	EU/1/20/1507/011	Netiekiama	-	-	No	-	-
111725	97839	1097839	flakonas	N10 (daugiadozis, 50 arba 100 dozių) (ciklinis olefinų polimeras)		Receptinis	EU/1/20/1507/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-06	Registruotas