EXJADE

Medicinal product

(Invented) name

EXJADE

Active substance (s)

Deferaziroksas

Strength

360 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)

V03AC03, Deferasirox

Marketing authorisation holder

Novartis Europharm Ltd., Airija

Date of authorisation

2006-08-28

Date of renewal

Documents

Exjade mokomoji medziaga pacientui.pdf

Exjade gydytojo kontrolinis sarasas.pdf

Exjade mokomoji medziaga sveikatos prieziuros specialistams.pdf

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.
Deferaziroksas	360 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
65506	80013	1080013	lizdinė plokštelė	N30		Receptinis	EU/1/06/356/017	Netiekiama	-	-	No	-	-
65507	80014	1080014	lizdinė plokštelė	N90		Receptinis	EU/1/06/356/018	Netiekiama	-	-	No	-	-
65508	80015	1080015	lizdinė plokštelė	N300 (10x30) (sudėtinė)		Receptinis	EU/1/06/356/019	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2006-08-28	Registruotas