ALUNBRIG

Country: Ինդոնեզիա

language: ինդոնեզերեն

source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

active_ingredient:

BRIGATINIB

MAH:

TAKEDA INDONESIA - Indonesia

INN:

BRIGATINIB

dosage:

180 Mg

pharmaceutical_form:

TABLET SALUT SELAPUT

units_in_package:

DUS, 4 BLISTER @ 7 TABLET SALUT SELAPUT

manufactured_by:

PENN PHARMACEUTICAL SERVICES LIMITED - United Kingdom

authorization_date:

2020-04-01

SPC

1 ALUNBRIG
BRIGATINIB 30 MG, 90 MG & 180 MG
TABLET
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Alunbrig 30 mg film-coated tablets
Alunbrig 90 mg film-coated tablets
Alunbrig 180 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Alunbrig 30 mg film-coated tablets
Each film-coated tablet contains 30 mg of brigatinib.
_Excipient with known effect_
Each film-coated tablet contains 56 mg of lactose monohydrate.
Alunbrig 90 mg film-coated tablets
Each film-coated tablet contains 90 mg of brigatinib.
_Excipient with known effect_
Each film-coated tablet contains 168 mg of lactose monohydrate.
Alunbrig 180 mg film-coated tablets
Each film-coated tablet contains 180 mg of brigatinib.
_Excipient with known effec_
t
Each film-coated tablet contains 336 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Alunbrig 30 mg film-coated tablets
Round, white to off-white film-coated tablet of approximately 7 mm in
diameter with debossed “U3”
on one side and plain on the other side.
Alunbrig 90 mg film-coated tablets
Oval, white to off-white film-coated tablet of approximately 15 mm in
length with debossed “U7” on
one side and plain on the other side.
Alunbrig 180 mg film-coated tablets
Oval, white to off-white film-coated tablet of approximately 19 mm in
length with debossed “U13” on
one side and plain on the other side.
DISETUJUI BPOM : 17/03/2020
ID : EREG10023511900062; EREG10023511900063
EREG10023511900064; EREG10023511900065
2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alunbrig is indicated as monotherapy for the treatment of adult
patients with anaplastic lymphoma
kinase (ALK)-positive metastatic non squamous non-small cell lung
cancer (NSCLC) progressed
with crizotinib.
4.2
POSOLOG