Omvoh

Medicinal product

(Invented) name

Omvoh

Active substance (s)

Mirikizumabas

Strength

100 mg

Pharmaceutical form

injekcinis tirpalas užpildytame švirkštiklyje

Route (s) of administration

leisti po oda

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

Solution for injection in pre-filled pen	1 ml
Mirikizumabas	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
111105	97216	1097216	užpildytas švirkštiklis	N2		Receptinis	EU/1/23/1736/004	Netiekiama	2025-09-12	2025-12-31	No	-	-
111106	97217	1097217	užpildytas švirkštiklis	N4 (2×2)		Receptinis	EU/1/23/1736/005	Netiekiama	-	-	No	-	-
111107	97218	1097218	užpildytas švirkštiklis	N6 (3×2)		Receptinis	EU/1/23/1736/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-26	Registruotas