Aflunov

Medicinal product

(Invented) name

Aflunov

Active substance (s)

Gripo viruso paviršiniai antigenai į A/turkey/Turkey/1/2005 (H5N1) panašios padermės (NIBRG-23) (grupė 2.2.1)

Strength

7,5 µg

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)

J07BB02, influenza, inactivated, split virus or surface antigen

Marketing authorisation holder

Seqirus S.r.l., Italija

Date of authorisation

2010-11-29

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

Suspension for injection	0.5 ml
Gripo viruso paviršiniai antigenai į A/turkey/Turkey/1/2005 (H5N1) panašios padermės (NIBRG-23) (grupė 2.2.1)	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
44189	57980	1057980	užpildytas švirkštas	0.5 ml N1		Receptinis	EU/1/10/658/001	Netiekiama	-	-	No	-	-
44190	57981	1057981	užpildytas švirkštas	0.5 ml N10		Receptinis	EU/1/10/658/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2010-11-29	Registruotas