BIMERVAX LP.8.1

Medicinal product

(Invented) name

BIMERVAX LP.8.1

Active substance (s)

COVID-19 vakcina (rekombinantinė, adjuvantinė). SARS-CoV-2 viruso rekombinantinio baltymo RBD suliejimo homodimeras (LP.8.1 – LP.8.1 padermė)

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 emulsijos) yra	0.5 ml
COVID-19 vakcina (rekombinantinė, adjuvantinė). SARS-CoV-2 viruso rekombinantinio baltymo RBD suliejimo homodimeras (LP.8.1 – LP.8.1 padermė)	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
118829	104936	1104936	flakonas	N10 (vienadozis, 10 dozių)	Receptinis	EU/1/22/1709/008	Netiekiama	-	-	No	-	-
118830	104937	1104937	flakonas	N20 (vienadozis, 20 dozių)	Receptinis	EU/1/22/1709/009	Netiekiama	-	-	No	-	-
118831	104938	1104938	flakonas	N1 (vienadozis, 1 dozė)	Receptinis	EU/1/22/1709/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-30	Registruotas