SAI - Detailed view

ALECENSA Kaps 150 mg 224 Stk

Drug

Name

Alecensa, Hartkapseln

Field of application

nicht-kleinzelliges Lungenkarzinom (NSCLC)

ATC

L01ED03 - ALECTINIB

07.16.1. – cytostatics

Use

HAM – Human medicine

pharmaceutical form

KAHA – Capsule, hard

Remedy code

S – synthetic products for human use

Dispensing categories

A – Dispensed once only on prescription by a physician or veterinarian (A)

Authorisation status

Z – approved

Authorisation number

65970

Initial registration date

1/26/2017

Expiry date

12/31/9999

Dosage strength

Name

Alecensa 150 mg, Hartkapseln

Field of application

nicht-kleinzelliges Lungenkarzinom (NSCLC)

Dosage strength number

Authorisation status

Z – approved

Package

GTIN**

7680659700013

Trade status*

No information made available

Status

A/R – Authorised / referenced

Package size

224 capsule(s)

Package code

001

Authorisation status

Z – approved

Declaration

Component

Active substance

150 mg alectinibum
alectinibi hydrochloridum

Excipient

33.67 mg lactosum monohydricum
hydroxypropylcellulosum
natrii laurilsulfas
6 mg natrium
carmellosum calcicum
magnesii stearas
carrageenanum
kalii chloridum
E 171
cera carnauba
maydis amylum
hypromellosum
E 172 (rubrum)
E 172 (flavum)
E 132
cera carnauba
lacca
polyglyceroli-3 mono-oleas