Omvoh

Medicinal product

(Invented) name

Omvoh

Active substance (s)

Mirikizumabas

Strength

100 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)

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 syringe	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
111103	97214	1097214	užpildytas švirkštas	N2		Receptinis	EU/1/23/1736/002	Netiekiama	-	-	No	-	-
111104	97215	1097215	užpildytas švirkštas	N6 (3×2)		Receptinis	EU/1/23/1736/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-26	Registruotas