BIMERVAX LP.8.1

Medicinal product

(Invented) name

BIMERVAX LP.8.1

Active substance (s)

Merakovateinas

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)

No

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

Search in EMA Europe

Stage

Registruotas

Controlled?

No

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
Merakovateinas	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
120760	106869	1106869	užpildytas švirkštas	N1 (1 dozė)		Receptinis	EU/1/22/1709/011	Netiekiama	-	-	No	-	-
120761	106870	1106870	užpildytas švirkštas	N10 (10 dozių)		Receptinis	EU/1/22/1709/012	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-03-30	Registruotas