Jakavi

Medicinal product

(Invented) name

Jakavi

Active substance (s)

Ruksolitinibas

Strength

15 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	15 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
57429	71545	1071545	lizdinė plokštelė	N14		Receptinis	EU/1/12/773/007	Netiekiama	-	-	No	-	-
57430	71546	1071546	lizdinė plokštelė	N56		Receptinis	EU/1/12/773/008	Netiekiama	-	-	No	-	-
57431	71547	1071547	lizdinė plokštelė	N168 (3x56)		Receptinis	EU/1/12/773/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2012-08-23	Registruotas