Deferasirox Accord

Medicinal product

(Invented) name

Deferasirox Accord

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

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 mokomoji medziaga pacientams.pdf

Deferasirox Accord gydytojo kontrolinis sarasas.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	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
103215	89316	1089316	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/19/1412/001	Netiekiama	-	-	No	-	-
103216	89317	1089317	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/19/1412/002	Netiekiama	-	-	No	-	-
103217	89318	1089318	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/19/1412/003	Netiekiama	-	-	No	-	-
103218	89319	1089319	dalomoji lizdinė plokštelė	N90×1		Receptinis	EU/1/19/1412/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-09	Registruotas