Spikevax LP.8.1

Medicinal product

(Invented) name

Spikevax LP.8.1

Active substance (s)

COVID-19 iRNR vakcina. SARS-CoV-2 LP.8.1 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

1 ml dispersijos yra	1 ml
COVID-19 iRNR vakcina. SARS-CoV-2 LP.8.1 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
118222	104330	1104330	flakonas	N10 (daugiadozis, stiklas) (50 arba 100 dozių)		Receptinis	EU/1/20/1507/031	Netiekiama	-	-	No	-	-
118223	104331	1104331	flakonas	N10 (daugiadozis, ciklinis olefinų polimeras) (50 arba 100 dozių)		Receptinis	EU/1/20/1507/032	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-01-06	Registruotas