Vepacel

Medicinal product

(Invented) name

Vepacel

Active substance (s)

Gripo virusas (iš neskaldytų virionų, inaktyvuotas), turintis antigenus A/Vietnam/1203/2004 (H5N1)

Strength

7,5 µg/dozėje

Pharmaceutical form

injekcinė suspensija užpildytame švirkšte

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BB01, Influenza, inactivated, whole virus

Marketing authorisation holder

Ology Bioservices Ireland Ltd., Airija

Date of authorisation

2012-02-17

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection	0.5 ml
Gripo virusas (iš neskaldytų virionų, inaktyvuotas), turintis antigenus A/Vietnam/1203/2004 (H5N1)	7,5 µg

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
51248	65141	1065141	flakonas	0,5 ml N20 (10 dozių)		Receptinis	EU/1/12/752/001	Netiekiama	-	-	No	-	-
54270	68260	1068260	užpildytas švirkštas	0,5 ml N1 (be švirkšto)		Receptinis	EU/1/12/752/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-10-02	Išregistruotas
2012-02-17	Registruotas