Omjjara

Medicinal product

(Invented) name

Omjjara

Active substance (s)

Momelotinibas

Strength

200 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EJ04, momelotinib

Marketing authorisation holder

GlaxoSmithKline Trading Services Limited, Airija

Date of authorisation

2024-01-25

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

Film-coated tablet	1 vnt.
Momelotinibas	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
112622	98742	1098742	buteliukas	N30		Receptinis	EU/1/23/1782/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-01-25	Registruotas