Klertis

Medicinal product

(Invented) name

Klertis

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

Egis Pharmaceuticals PLC, Vengrija

Date of authorisation

2021-04-29

Date of renewal

Documents

4737_4739 Pakuotės lapelis 2024 06 26.docx

4737_4739 Klertis PCS PL 2024 06 26.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

NL/H/5076/001/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
106456	92557	1092557	lizdinė plokštelė	N28		Receptinis	LT/1/21/4737/001	Tiekiama	-	-	No	-	-
106457	92558	1092558	buteliukas	N30		Receptinis	LT/1/21/4737/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2021-04-29	Registruotas