Deferasirox Mylan

Medicinal product

(Invented) name

Deferasirox Mylan

Active substance (s)

Deferaziroksas

Strength

90 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	90 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
102460	88561	1088561	lizdinė plokštelė	N30		Receptinis	EU/1/19/1386/001	Netiekiama	-	-	No	-	-
102462	88563	1088563	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/19/1386/002	Netiekiama	-	-	No	-	-
102461	88562	1088562	lizdinė plokštelė	N90		Receptinis	EU/1/19/1386/003	Netiekiama	-	-	No	-	-
102463	88564	1088564	buteliukas	N90		Receptinis	EU/1/19/1386/004	Netiekiama	-	-	No	-	-
102464	88565	1088565	buteliukas	N300		Receptinis	EU/1/19/1386/005	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-26	Registruotas