Capecitabine Zentiva

Medicinal product

(Invented) name

Capecitabine Zentiva

Active substance (s)

Kapecitabinas

Strength

500 mg

Pharmaceutical form

plėvele dengtos tabletės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01BC06, Capecitabine

Marketing authorisation holder

Zentiva k.s., Čekija

Date of authorisation

2012-12-05

Date of renewal

2018-05-29

Documents

3145 Capecitabine Zentiva tab PCS PL 2021_04_14.docx

3145_1_2 Pakuotės lapelis 2021_04_14.docx

Stage

Perregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

LV/H/0167/002

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Kapecitabinas	500 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
48576	62405	1062405	lizdinė plokštelė	N120		Receptinis	LT/1/12/3145/002	Tiekiama	-	-	No	-	-	Download

Stadijos

Data	Stadija
2018-05-29	Perregistruotas
2012-12-05	Registruotas