Beyfortus

Medicinal product

(Invented) name

Beyfortus

Active substance (s)

Nirsevimabas

Strength

50 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	0.5 ml
Nirsevimabas	50 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
109690	95796	1095796	užpildytas švirkštas	N1		Receptinis	EU/1/22/1689/001	Netiekiama	-	-	No	-	-
109691	95797	1095797	užpildytas švirkštas	N1 (su 2 adatomis)		Receptinis	EU/1/22/1689/002	Netiekiama	-	-	No	-	-
109692	95798	1095798	užpildytas švirkštas	N5		Receptinis	EU/1/22/1689/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-31	Registruotas