Imatinib Actavis Group

Medicinal product

(Invented) name

Imatinib Actavis Group

Active substance (s)

Imatinibas

Strength

400 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)

L01XE01, Imatinib

Marketing authorisation holder

Actavis Group PTC ehf., Islandija

Date of authorisation

2015-11-18

Date of renewal

Documents

3836_1_16 Imatinib Actavis PCS PL 161031.docx

Stage

Išregistruotas

Controlled?

No

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/1424/004/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Imatinibas	400 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
58817	73033	1073033	lizdinė plokštelė	N30		Receptinis	LT/1/15/3836/013	Netiekiama	-	-	No	-	-
64243	78703	1078703	lizdinė plokštelė	N60		Receptinis	LT/1/15/3836/014	Netiekiama	-	-	No	-	-
64244	78704	1078704	lizdinė plokštelė	N90		Receptinis	LT/1/15/3836/015	Netiekiama	-	-	No	-	-
64245	78705	1078705	lizdinė plokštelė	N120		Receptinis	LT/1/15/3836/016	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2016-12-07	Išregistruotas
2015-11-18	Registruotas