LORLAK

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

LORLATINIB

Disponible depuis:

PFIZER INDONESIA - Indonesia

DCI (Dénomination commune internationale):

LORLATINIB

Dosage:

25.000 MG

forme pharmaceutique:

TABLET SALUT SELAPUT

Unités en paquet:

DUS, 1 BLISTER @ 10 TABLET SALUT SELAPUT

Fabriqué par:

PFIZER MANUFACTURING DEUTSCHLAND GMBH - Federal Republic of Germany

Date de l'autorisation:

2022-03-21

Résumé des caractéristiques du produit

Generic Name: Lorlatinib
Trade Name: LORLAK
®
CDS Effective Date: November 11, 2020
Supersedes: September 11, 2020
Approved by BPOM:
2019-0057286; 2020-0064623
Page 1 of 28
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Lorlatinib
Trade Name: LORLAK
®
CDS Effective Date: November 11, 2020
Supersedes: September 11, 2020
1. NAME OF THE MEDICINAL PRODUCT
1.1.
PRODUCT NAME
LORLAK
®
1.2. STRENGTH
25 mg and 100 mg
1.3.
PHARMACEUTICAL DOSAGE FORM
Film-coated tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg film-coated tablet contains 25 mg of lorlatinib.
Each 100 mg film-coated tablet contains 100 mg of lorlatinib.
For the full list of excipients, see Section 6.1.
STRUCTURE
O
N
O
M
e
M
e
N
N
M
e
C
N
N
H
2
N
F
R
3. PHARMACEUTICAL FORM
25 mg: Round light pink film-coated tablet, debossed with “Pfizer”
on one side and “25” and
“
LLN” on the other side.
100 mg: Oval dark pink film-coated tablet, debossed with “Pfizer”
on one side and “LLN 100”
on the other side.
DISETUJUI OLEH BPOM: 28/02/2023
ID: EREG10024112200622
EREG10024112200623
Generic Name: Lorlatinib
Trade Name: LORLAK
®
CDS Effective Date: November 11, 2020
Supersedes: September 11, 2020
Approved by BPOM:
2019-0057286; 2020-0064623
Page 2 of 28
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
LORLAK
®
as monotherapy is indicated for the treatment of adult patients with
anaplastic
lymphoma kinase (ALK)-positive locally advanced or metastatic
non-small cell lung cancer
(NSCLC) previously not treated with an ALK inhibitor.
LORLAK
®
is indicated for the treatment of adult patients with ALK-positive
advanced NSCLC
whose disease has progressed after previously treated with one or more
ALK tyrosine kinase
inhibitors (TKIs).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with lorlatinib should be initiated and supervised by a
physician experienced in the
use of anticancer medicinal products.
ALK testing
ALK-positive status should be established using a validated ALK assay.
Detection of ALK
positive NSCLC is neces