VYEPTI

Medicinal product

(Invented) name

VYEPTI

Active substance (s)

Eptinezumabas

Strength

100 mg

Pharmaceutical form

koncentratas infuziniam tirpalui

Route (s) of administration

leisti į veną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N02CD05, eptinezumab

Marketing authorisation holder

H.Lundbeck A/S, Danija

Date of authorisation

2022-01-24

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

Kiekviename koncentrato flakone yra	1 ml
Eptinezumabas	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
107941	94046	1094046	flakonas	N1		Receptinis	EU/1/21/1599/001	Netiekiama	2025-01-03	2026-04-01	Yes	2025-01-03	2025-12-31
109903	96010	1096010	flakonas	N3		Receptinis	EU/1/21/1599/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-01-24	Registruotas