BIMERVAX XFG.1.1

Medicinal product

(Invented) name

BIMERVAX XFG.1.1

Active substance (s)

SARS-CoV-2 viruso rekombinantinio baltymo RBD sulieto homodimero (XFG.1.1 – XFG.1.1) su adjuvantu SQBA

Strength

40 µg/dozėje

Pharmaceutical form

injekcinė emulsija užpildytame švirkšte

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BN04, covid-19, protein subunit

Marketing authorisation holder

Hipra Human Health, S.L.U., Ispanija

Date of authorisation

2023-03-23

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 (0,5 ml) yra	0.5 ml
SARS-CoV-2 viruso rekombinantinio baltymo RBD sulieto homodimero (XFG.1.1 – XFG.1.1) su adjuvantu SQBA	40 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
121777	107886	1107886	užpildytas švirkštas	N1 (1 dozė)		Receptinis	EU/1/22/1709/016	Netiekiama	-	-	No	-	-
121778	107887	1107887	užpildytas švirkštas	N10 (10 dozių)		Receptinis	EU/1/22/1709/017	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-23	Registruotas