Deferasirox Mylan

Medicinal product

(Invented) name

Deferasirox Mylan

Active substance (s)

Deferaziroksas

Strength

180 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	180 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
102465	88566	1088566	lizdinė plokštelė	N30		Receptinis	EU/1/19/1386/006	Netiekiama	-	-	No	-	-
102467	88568	1088568	dalomoji lizdinė plokštelė	N30x1		Receptinis	EU/1/19/1386/007	Netiekiama	-	-	No	-	-
102466	88567	1088567	lizdinė plokštelė	N90		Receptinis	EU/1/19/1386/008	Netiekiama	-	-	No	-	-
102468	88569	1088569	buteliukas	N90		Receptinis	EU/1/19/1386/009	Netiekiama	-	-	No	-	-
102469	88570	1088570	buteliukas	N300		Receptinis	EU/1/19/1386/010	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2019-09-26	Registruotas