Spikevax XFG

Medicinal product

(Invented) name

Spikevax XFG

Active substance (s)

SARS-CoV-2 XFG 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

Daugiadozis flakonas (2,5 ml)	1 ml
SARS-CoV-2 XFG 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
121789	107897	1107897	flakonas	N10 (stiklas, daugiadozis, 50 arba 100 dozių)		Receptinis	EU/1/20/1507/041	Netiekiama	-	-	No	-	-
121790	107898	1107898	flakonas	N10 (ciklinis olefinų polimeras, daugiadozis, 50 arba 100 dozių)		Receptinis	EU/1/20/1507/042	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-06	Registruotas