Suphrex

Medicinal product

(Invented) name

Suphrex

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

LV System Service SIA, Latvija

Date of authorisation

2022-10-03

Date of renewal

Documents

5037-5038_Suphrex.docx

LT-0159-1-2-DC_AR_SDS+LT apžvalga.pdf

5037-5038_pakuotes lapelis_2022-10-03.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LT/H/0159/001/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
109527	95632	1095632	lizdinė plokštelė	N28		Receptinis	LT/1/22/5037/001	Netiekiama	-	-	No	-	-
109528	95633	1095633	buteliukas	N30		Receptinis	LT/1/22/5037/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2022-10-03	Registruotas