Imatinib Actavis Group

Medicinal product

(Invented) name

Imatinib Actavis Group

Active substance (s)

Imatinibas

Strength

100 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/1424/001/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Tabletėje yra	1 vnt.
Imatinibas	100 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
58814	73030	1073030	lizdinė plokštelė	N30		Receptinis	LT/1/15/3836/001	Netiekiama	-	-	No	-	-
64234	78694	1078694	lizdinė plokštelė	N60		Receptinis	LT/1/15/3836/002	Netiekiama	-	-	No	-	-
64235	78695	1078695	lizdinė plokštelė	N90		Receptinis	LT/1/15/3836/003	Netiekiama	-	-	No	-	-
64236	78696	1078696	lizdinė plokštelė	N120		Receptinis	LT/1/15/3836/004	Netiekiama	-	-	No	-	-

Stadijos

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