Vyvgart

Medicinal product

(Invented) name

Vyvgart

Active substance (s)

Efgartigimodas alfa

Strength

1000 mg

Pharmaceutical form

injekcinis tirpalas

Route (s) of administration

leisti po oda

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AA58, efgartigimod alfa

Marketing authorisation holder

argenx BV, Belgija

Date of authorisation

2022-08-10

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

Flakone (5,6 ml tirpalo) yra	5.6 ml
Efgartigimodas alfa	1000 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
112023	98138	1098138	flakonas	N1		Receptinis	EU/1/22/1674/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-10	Registruotas