Omvoh

Medicinal product

(Invented) name

Omvoh

Active substance (s)

Mirikizumabas

Strength

300 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)

L04AC24, Mirikizumabas

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2023-05-26

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

Concentrate for solution for infusion	15 ml
Mirikizumabas	300 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
111102	97213	1097213	flakonas	15 ml N1		Receptinis	EU/1/23/1736/001	Netiekiama	-	2025-12-31	Yes	2025-09-17	2025-12-31
116753	102856	1102856	flakonas	15 ml N3 (3×1)		Receptinis	EU/1/23/1736/011	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-26	Registruotas