Abrysvo

Medicinal product

(Invented) name

Abrysvo

Active substance (s)

RSV-A atmainos stabilizuotas prefuzijos F antigenas/RSV-B atmainos stabilizuotas prefuzijos F antigenas

Strength

60 µg/60 µg

Pharmaceutical form

milteliai ir tirpiklis injekciniam tirpalui daugiadozėje talpyklėje

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

J07BX05, respiratory syncytial virus vaccines

Marketing authorisation holder

Pfizer Europe MA EEIG, Belgija

Date of authorisation

2023-08-23

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

Vienos dozės (0,5 ml) sudėtis paruošus	0.5 ml
RSV-A atmainos stabilizuotas prefuzijos F antigenas	60 µg
RSV-B atmainos stabilizuotas prefuzijos F antigenas	60 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
120533	106637	1106637	flakonas	N10 (antigenai 30 dozių + tirpiklis 30 dozių)		Receptinis	EU/1/23/1752/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-08-23	Registruotas