Pandemic influenza vaccine H5N1 AstraZeneca (Pandeminė vakcina nuo gripo H5N1 AstraZeneca)

Medicinal product

(Invented) name

Active substance (s)

Gyvi susilpninti gripo virusai: A/Vietnam/1203/2004 (H5N1) (A/Vietnam/1203/2004, MEDI 0141000136) padermės

Strength

10 (7±0,5) FŽV/0,2ml

Pharmaceutical form

nosies purškalas (suspensija)

Route (s) of administration

vartoti į nosį

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BB03, Influenza, live attenuated

Marketing authorisation holder

AstraZeneca AB, Švedija

Date of authorisation

2016-05-20

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Nasal spray, suspension	0.2 ml
Gyvi susilpninti gripo virusai: A/Vietnam/1203/2004 (H5N1) (A/Vietnam/1203/2004, MEDI 0141000136) padermės	10 (7±0,5) FŽV/0,2ml

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
65867	80379	1080379	aplikatorius	0,2 ml N10		Receptinis	EU/1/16/1089/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-05-20	Registruotas