Alecensa

Medicinal product

(Invented) name

Alecensa

Active substance (s)

Alektinibas

Strength

150 mg

Pharmaceutical form

kietosios kapsulės

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

L01ED03, alectinib

Marketing authorisation holder

Roche Registration GmbH, Vokietija

Date of authorisation

2017-02-16

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Capsule, hard	1 vnt.
Alektinibas	150 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
67760	82317	1082317	lizdinė plokštelė	N224 (4x56)		Receptinis	EU/1/16/1169/001	Tiekiama	-	-	No	-	-
102843	88944	1088944	buteliukas	N240		Receptinis	EU/1/16/1169/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2017-02-16	Registruotas