Deferasirox Accord

Medicinal product

(Invented) name

Deferasirox Accord

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

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2020-01-09

Date of renewal

Documents

Deferasirox Accord gydytojo kontrolinis sarasas.pdf

Deferasirox Accord mokomoji medziaga pacientams.pdf

Deferasirox Accord mokomoji medziaga sveikatos prieziuros specialistams.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	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
103223	89324	1089324	dalomoji lizdinė plokštelė	N28×1		Receptinis	EU/1/19/1412/009	Netiekiama	-	-	No	-	-
103224	89325	1089325	dalomoji lizdinė plokštelė	N30×1		Receptinis	EU/1/19/1412/010	Netiekiama	-	-	No	-	-
103225	89326	1089326	dalomoji lizdinė plokštelė	N56×1		Receptinis	EU/1/19/1412/011	Netiekiama	-	-	No	-	-
103226	89327	1089327	dalomoji lizdinė plokštelė	N90×1		Receptinis	EU/1/19/1412/012	Netiekiama	-	-	No	-	-
108058	94162	1094162	dalomoji lizdinė plokštelė	N100×1		Receptinis	EU/1/19/1412/013	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2020-01-09	Registruotas