JCOVDEN [COVID-19 Vaccine Janssen]

Medicinal product

(Invented) name

JCOVDEN [COVID-19 Vaccine Janssen]

Active substance (s)

COVID-19 vakcina (Ad26.COV2-S (rekombinantinė))

Strength

8,92 log(10) inf.V

Pharmaceutical form

injekcinė suspensija

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J07BN02, covid-19, viral vector, non-replicating

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2021-03-11

Date of renewal

Documents

Search in EMA Europe

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection. One dose (0.5 mL) contains not less than:	0.5 ml
COVID-19 vakcina (Ad26.COV2-S (rekombinantinė))	8,92 log(10) inf.V

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
106141	92242	1092242	flakonas	N10 (daugiadozis, 50 dozių)		Receptinis	EU/1/20/1525/001	Netiekiama	-	-	No	-	-
106352	92453	1092453	flakonas	N20 (daugiadozis, 100 dozių)		Receptinis	EU/1/20/1525/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-09	Išregistruotas
2021-03-11	Registruotas