Vyvgart

Medicinal product

(Invented) name

Vyvgart

Active substance (s)

Efgartigimodas alfa

Strength

1000 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkšte

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

Užpildytame švirkšte (5 ml) yra	5 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
117423	103528	1103528	užpildytas švirkštas	N1		Receptinis	EU/1/22/1674/003	Netiekiama	-	-	No	-	-
117424	103529	1103529	užpildytas švirkštas	N4		Receptinis	EU/1/22/1674/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-08-10	Registruotas