Olumiant

Medicinal product

(Invented) name

Olumiant

Active substance (s)

Baricitinibas

Strength

2 mg/ml

Pharmaceutical form

geriamoji suspensija

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L04AF02, Baricitinib

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2017-02-13

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

1 ml suspensijos yra	1 ml
Baricitinibas	2 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
120687	106794	1106794	buteliukas	7,5 ml N1 (+geriamasis švirkštas, buteliuko adapteris)		Receptinis	EU/1/16/1170/020	Netiekiama	-	-	No	-	-
120688	106795	1106795	buteliukas	30 ml N1 (+geriamasis švirkštas, buteliuko adapteris)		Receptinis	EU/1/16/1170/021	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-02-13	Registruotas