Zabdeno

Medicinal product

(Invented) name

Zabdeno

Active substance (s)

Ad26.ZEBOV-GP (gyvoji)

Strength

>8,75 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)

J07BX02, ebola virus, live attenuated

Marketing authorisation holder

Janssen-Cilag International N.V., Belgija

Date of authorisation

2020-07-01

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

Suspension for injection	0.5 ml
Ad26.ZEBOV-GP (gyvoji)	>8,75 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
104637	90739	1090739	flakonas	0,5 ml N20		Receptinis	EU/1/20/1444/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-07-01	Registruotas