Sunitinib Accord

Medicinal product

(Invented) name

Sunitinib Accord

Active substance (s)

Sunitinibas

Strength

37,5 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	37,5 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
106051	92152	1092152	lizdinė plokštelė	N28		Receptinis	EU/1/20/1511/007	Netiekiama	-	-	No	-	-
106054	92155	1092155	dalomoji lizdinė plokštelė	N28x1		Receptinis	EU/1/20/1511/008	Netiekiama	-	-	No	-	-
106058	92159	1092159	buteliukas	N30		Receptinis	EU/1/20/1511/009	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-02-11	Registruotas