Sunitinib Viatris [Sunitinib Mylan]

Medicinal product

(Invented) name

Sunitinib Viatris [Sunitinib Mylan]

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

Viatris Limited, Airija

Date of authorisation

2019-04-30

Date of renewal

2023-12-22

Documents

4378_4379 Sunitinib Viatris RPP 2024 12 02.docx

4378_4379 Pakuotės lapelis 2024 12 02.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/4253/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Kapsulėje yra	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
101481	87584	1087584	lizdinė plokštelė	N28		Receptinis	LT/1/19/4378/001	Tiekiama	-	-	No	-	-
101482	87585	1087585	dalomoji lizdinė plokštelė	N28x1		Receptinis	LT/1/19/4378/002	Netiekiama	-	-	No	-	-
101483	87586	1087586	buteliukas	N30		Receptinis	LT/1/19/4378/003	Netiekiama	-	-	No	-	-
105953	92053	1092053	dalomoji lizdinė plokštelė	N30x1		Receptinis	LT/1/19/4378/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2023-12-22	Perregistruotas
2019-04-30	Registruotas