Fluenz

Medicinal product

(Invented) name

Fluenz

Active substance (s)

Į A/Missouri/11/2025 (H1N1)pdm09 panaši padermė (A/Switzerland/6849/2025, MEDI 400592)/Į A/Darwin/1454/2025 (H3N2) panaši padermė (A/Darwin/1369/2025, MEDI 406666)/Į B/Tokyo/EIS13-175/2025 panaši padermė (B/Perth/115/2025, MEDI 407730)

Strength

10 (×7,0±0,5)/10 (×7,0±0,5)/10 (×7,0±0,5)

Pharmaceutical form

nosies purškalas (suspensija)

Route (s) of administration

vartoti į nosį

Purpose for use

2026-2027 sezonas

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

2024-06-03

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Pergrupuoti gripo virusai (gyvi susilpninti) trijų padermių	0.2 ml
Į A/Missouri/11/2025 (H1N1)pdm09 panaši padermė (A/Switzerland/6849/2025, MEDI 400592)	10 (×7,0±0,5)
Į A/Darwin/1454/2025 (H3N2) panaši padermė (A/Darwin/1369/2025, MEDI 406666)	10 (×7,0±0,5)
Į B/Tokyo/EIS13-175/2025 panaši padermė (B/Perth/115/2025, MEDI 407730)	10 (×7,0±0,5)

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
113851	99968	1099968	nosies aplikatorius	0,2 ml N1		Receptinis	EU/1/24/1816/001	Netiekiama	-	-	No	-	-
113852	99969	1099969	nosies aplikatorius	0,2 ml N10		Receptinis	EU/1/24/1816/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-06-03	Registruotas