Deferasirox Accord

Medicinal product

(Invented) name

Deferasirox Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2020-01-09

Date of renewal

Documents

Deferasirox Accord mokomoji medziaga sveikatos prieziuros specialistams.pdf

Deferasirox Accord gydytojo kontrolinis sarasas.pdf

Deferasirox Accord mokomoji medziaga pacientams.pdf

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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
103219	89320	1089320	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/19/1412/005	Netiekiama	-	-	No	-	-
103220	89321	1089321	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/19/1412/006	Netiekiama	-	-	No	-	-
103221	89322	1089322	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/19/1412/007	Netiekiama	-	-	No	-	-
103222	89323	1089323	dalomoji lizdinė plokštelė	N90×1		Receptinis	EU/1/19/1412/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-09	Registruotas