Olumiant

Medicinal product

(Invented) name

Olumiant

Active substance (s)

Baricitinibas

Strength

1 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)

L04AF02, Baricitinib

Marketing authorisation holder

Eli Lilly Nederland B.V., Nyderlandai

Date of authorisation

2017-02-13

Date of renewal

Documents

Olumiant paciento kortele.pdf

Mokomoji medziaga sveikatos prieziuros specialistams_AD_AD_vaikams.pdf

Olumiant mokomoji medziaga sveikatos prieziuros specialistams_RA.pdf

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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.
Baricitinibas	1 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
111609	97722	1097722	lizdinė plokštelė	N14		Receptinis	EU/1/16/1170/017	Netiekiama	-	-	No	-	-
111610	97723	1097723	lizdinė plokštelė	N28		Receptinis	EU/1/16/1170/018	Netiekiama	-	-	No	-	-
111611	97724	1097724	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/16/1170/019	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-02-13	Registruotas