mCOMBRIAX

Medicinal product

(Invented) name

mCOMBRIAX

Active substance (s)

A/Wisconsin/67/2022 (A/H1N1)pdm09/A/Darwin/6/2021 (A/H3N2)/B/Austria/1359417/2021 (B/Victoria linija)/SARS-CoV-2 Omicron XBB.1.5

Strength

8,3 µg/8,3 µg/8,3 µg/6,7 µg/dozėje

Pharmaceutical form

injekcinė dispersija užpildytame švirkšte

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

Nesuteiktas, Netaikoma ar nesuteiktas

Marketing authorisation holder

Moderna Biotech Spain, S.L., Ispanija

Date of authorisation

2026-04-20

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

Dozėje (0,32 ml injekcinės disperdijos) yra	0.32 ml
A/Wisconsin/67/2022 (A/H1N1)pdm09	8,3 µg
A/Darwin/6/2021 (A/H3N2)	8,3 µg
B/Austria/1359417/2021 (B/Victoria linija)	8,3 µg
SARS-CoV-2 Omicron XBB.1.5	6,7 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
120587	106691	1106691	užpildytas švirkštas	N1 (padėkle)		Receptinis	EU/1/26/2028/001	Netiekiama	-	-	No	-	-
120588	106692	1106692	užpildytas švirkštas	N10 (padėkle)		Receptinis	EU/1/26/2028/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-04-20	Registruotas