Focetria

Medicinal product

(Invented) name

Focetria

Active substance (s)

A/California/07/2009 (H1N1) padermė naudojant NYMC X-181

Strength

15 µg/0,5 ml

Pharmaceutical form

injekcinė suspensija

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

Novartis Vaccines and Diagnostics S.r.l., Italija

Date of authorisation

2007-05-02

Date of renewal

Documents

Stage

Išregistruotas

Controlled?

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Suspension for injection	0.5 ml
A/California/07/2009 (H1N1) padermė naudojant NYMC X-181	15 µg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To
25820	28412	1028412	užpildytas švirkštas	0.5 ml- N1	Receptinis	EU/1/07/385/001	Netiekiama	-	-	No	-	-
25821	28413	1028413	užpildytas švirkštas	0.5 ml-N10	Receptinis	EU/1/07/385/002	Netiekiama	-	-	No	-	-
25823	28415	1028415	užpildytas švirkštas	N10 (daugiadozė: 10 dozių)	Receptinis	EU/1/07/385/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
	Išregistruotas
2007-05-02	Registruotas