Deferasirox Mylan

Medicinal product

(Invented) name

Deferasirox Mylan

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

Mylan Pharmaceuticals Limited, Airija

Date of authorisation

2019-09-26

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

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
102470	88571	1088571	lizdinė plokštelė	N30		Receptinis	EU/1/19/1386/011	Netiekiama	-	-	No	-	-
102473	88574	1088574	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/19/1386/012	Netiekiama	-	-	No	-	-
102471	88572	1088572	lizdinė plokštelė	N90		Receptinis	EU/1/19/1386/013	Netiekiama	-	-	No	-	-
102472	88573	1088573	lizdinė plokštelė	N300		Receptinis	EU/1/19/1386/014	Netiekiama	-	-	No	-	-
102474	88575	1088575	buteliukas	N90		Receptinis	EU/1/19/1386/015	Netiekiama	-	-	No	-	-
102475	88576	1088576	buteliukas	N300		Receptinis	EU/1/19/1386/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-26	Registruotas