BIMERVAX XBB.1.16

Medicinal product

(Invented) name

BIMERVAX XBB.1.16

Active substance (s)

COVID-19 vakcina (rekombinantinė, adjuvantinė). Damlekovateinas

Strength

40 µg/dozėje

Pharmaceutical form

injekcinė emulsija

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

2023-03-30

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 suspensijos) yra	0.5 ml
COVID-19 vakcina (rekombinantinė, adjuvantinė). Damlekovateinas	40 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
116051	102152	1102152	flakonas	0,5 ml N5 (5 dozės)	Receptinis	EU/1/22/1709/005	Netiekiama	-	-	No	-	-
116052	102153	1102153	flakonas	0,5 ml N10 (10 dozių)	Receptinis	EU/1/22/1709/006	Netiekiama	-	-	No	-	-
116053	102154	1102154	flakonas	0,5 ml N20 (20 dozių)	Receptinis	EU/1/22/1709/007	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-30	Registruotas