Jakavi

Medicinal product

(Invented) name

Jakavi

Active substance (s)

Ruksolitinibas

Strength

5 mg

Pharmaceutical form

tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EJ01, ruxolitinib

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2012-08-23

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

Tablet	1 vnt.
Ruksolitinibas	5 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
57426	71542	1071542	lizdinė plokštelė	N14		Receptinis	EU/1/12/773/004	Netiekiama	-	-	No	-	-
57427	71543	1071543	lizdinė plokštelė	N56		Receptinis	EU/1/12/773/005	Tiekiama	-	-	No	-	-
57428	71544	1071544	lizdinė plokštelė	N168 (3x56)		Receptinis	EU/1/12/773/006	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-08-23	Registruotas