Sunitinib G.L. Pharma

Medicinal product

(Invented) name

Sunitinib G.L. Pharma

Active substance (s)

Sunitinibas

Strength

25 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

G.L. Pharma GmbH, Austrija

Date of authorisation

2020-12-22

Date of renewal

2025-08-21

Documents

4662(63_64)_pakuotes lapelis_2025-08-21.docx

4662(63_64)_Sunit_G_L Pharma_perr2025-08-21.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4975/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	1 vnt.
Sunitinibas	25 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
105562	91662	1091662	lizdinė plokštelė	N28		Receptinis	LT/1/20/4663/001	Netiekiama	-	-	No	-	-
105563	91663	1091663	lizdinė plokštelė	N30		Receptinis	LT/1/20/4663/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-08-21	Perregistruotas
2020-12-22	Registruotas