Capecitabine Zentiva k.s.

Medicinal product

(Invented) name

Capecitabine Zentiva k.s.

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

2024-08-05

Date of renewal

Documents

5522-23_pakuotes lapelis_2024-08-05.docx

5522-5523_Capecitabine Zentiva ks.docx

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

DE/H/5462/002/E/002

Marketing authorisation procedure

Kartotinė 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
114362	100473	1100473	lizdinė plokštelė	N120		Receptinis	LT/1/24/5523/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2024-08-05	Registruotas