Omvoh

Medicinal product

(Invented) name

Omvoh

Active substance (s)

Mirikizumabas+Mirikizumabas

Strength

100 mg + 200 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

Užpildytame švirkšte (1 ml tirpalo) yra	1 ml
Mirikizumabas	100 mg
Užpildytame švirkšte (2 ml tirpalo) yra	2 ml
Mirikizumabas	200 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
116700	102801	1102801	užpildytas švirkštas	N1×100 mg + N1×200 mg		Receptinis	EU/1/23/1736/007	Netiekiama	-	-	No	-	-
116701	102802	1102802	užpildytas švirkštas	N3 (3×1) ×100 mg + N3 (3×1) × 200 mg		Receptinis	EU/1/23/1736/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-05-26	Registruotas