Beyfortus

Medicinal product

(Invented) name

Beyfortus

Active substance (s)

Nirsevimabas

Strength

100 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

J06BD08, nirsevimab

Marketing authorisation holder

Sanofi Winthrop Industrie, Prancūzija

Date of authorisation

2022-10-31

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

Solution for injection in pre-filled syringe	1 ml
Nirsevimabas	100 mg

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
109693	95799	1095799	užpildytas švirkštas	N1		Receptinis	EU/1/22/1689/004	Netiekiama	-	-	No	-	-
109694	95800	1095800	užpildytas švirkštas	N1 (su 2 adatomis)		Receptinis	EU/1/22/1689/005	Netiekiama	-	-	No	-	-
109695	95801	1095801	užpildytas švirkštas	N5		Receptinis	EU/1/22/1689/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-31	Registruotas