Capecitabine Actavis

Medicinal product

(Invented) name

Capecitabine Actavis

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

Actavis Group PTC ehf, Islandija

Date of authorisation

2012-06-29

Date of renewal

Documents

2995_1_2 Capecitabine Actavis II PL 160212.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

BE/H/0198/002/DC

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
45223	59022	1059022	lizdinė plokštelė	N120		Receptinis	LT/1/12/2995/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-03-23	Išregistruotas
2012-06-29	Registruotas