VaxigripTetra

Medicinal product

(Invented) name

VaxigripTetra

Active substance (s)

A/Victoria/4897/2022 (H1N1)pdm09 panaši padermė (A/Victoria/4897/2022 IVR‐238)/A/Darwin/9/2021 (H3N2) panaši padermė (A/Darwin/9/2021, IVR-228)/B/Austria/1359417/2021 panaši padermė (B/Michigan/01/2021, laukinio tipo)/Į B/Phuket/3073/2013 panaši padermė (B/Phuket/3073/2013, laukinis tipas)

Strength

15 µg HA/15 µg HA/15 µg HA/15 µg HA

Pharmaceutical form

injekcinė suspensija užpildytame švirkšte

Route (s) of administration

leisti į raumenis, leisti po oda

Purpose for use

2022-2023 sezonas

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BB02, influenza, inactivated, split virus or surface antigen

Marketing authorisation holder

UAB Lex ano, Lietuva

Date of authorisation

2022-11-17

Date of renewal

Documents

1770_VaxigripTetra_2022-11-17.docx

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

Procedure number

Marketing authorisation procedure

Lygiagretus importas

Qualitative and quantitative composition

0,5 ml dozėje yra	0.5 ml
A/Victoria/4897/2022 (H1N1)pdm09 panaši padermė (A/Victoria/4897/2022 IVR‐238)	15 µg HA
A/Darwin/9/2021 (H3N2) panaši padermė (A/Darwin/9/2021, IVR-228)	15 µg HA
B/Austria/1359417/2021 panaši padermė (B/Michigan/01/2021, laukinio tipo)	15 µg HA
Į B/Phuket/3073/2013 panaši padermė (B/Phuket/3073/2013, laukinis tipas)	15 µg HA

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
109864	95971	1095971	užpildytas švirkštas	0,5 ml su adata N1	ASPĮ	Receptinis	LT/L/22/1770/001	Netiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2022-11-17	Registruotas