Sunitinib Accord

Medicinal product

(Invented) name

Sunitinib Accord

Active substance (s)

Sunitinibas

Strength

12,5 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01EX01, sunitinib

Marketing authorisation holder

Accord Healthcare S.L.U., Ispanija

Date of authorisation

2021-02-11

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

Capsule, hard	1 vnt.
Sunitinibas	12,5 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
106048	92149	1092149	lizdinė plokštelė	N28		Receptinis	EU/1/20/1511/001	Netiekiama	-	-	No	-	-
106049	92150	1092150	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/20/1511/002	Tiekiama	-	-	No	-	-
106056	92157	1092157	buteliukas	N30		Receptinis	EU/1/20/1511/003	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-11	Registruotas