BIMERVAX

Medicinal product

(Invented) name

BIMERVAX

Active substance (s)

COVID-19 vakcina (rekombinantinė, adjuvantinė). Selvakovateinas

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) yra	0.5 ml
COVID-19 vakcina (rekombinantinė, adjuvantinė). Selvakovateinas	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
110757	96868	1096868	flakonas	N10 (daugiadozis, 100 dozių)	Receptinis	EU/1/22/1709/001	Netiekiama	-	-	No	-	-
113412	99530	1099530	flakonas	N5 (vienadoziai, 5 dozės)	Receptinis	EU/1/22/1709/002	Netiekiama	-	-	No	-	-
113413	99531	1099531	flakonas	N10 (vienadozis, 10 dozių)	Receptinis	EU/1/22/1709/003	Netiekiama	-	-	No	-	-
113414	99532	1099532	flakonas	N20 (vienadozis, 20 dozių)	Receptinis	EU/1/22/1709/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-30	Registruotas