IMFINZI

Country: Indonesia

Bahasa: Indonesia

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

Bahan aktif:

DURVALUMAB

Boleh didapati daripada:

ASTRAZENECA INDONESIA - Indonesia

INN (Nama Antarabangsa):

DURVALUMAB

Dos:

120 MG

Borang farmaseutikal:

LARUTAN KONSENTRAT UNTUK INFUS

Unit dalam pakej:

DUS, 1 VIAL @ 2.4 ML

Dikeluarkan oleh:

CATALENT INDIANA LLC - United States of America

Tarikh kebenaran:

2020-10-31

Ciri produk

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PROPOSED PACKAGING MATERIAL
Code
Imfinzi 120 mg & 500 mg – PI-01.02
Submission
NDA
Renewal
Variation change detail no.: MU-121496-146080 and MU-124598-150201_ _
Code of previous version
N/A
Changes
Posology Update 1500 mg Q4W for NSCLC indication, Table 2. Management
of Adverse Effect
(dose modification, Addition Myasthenia Gravis and Update Diabetes
Melitus type 1), Pancreatitits
Reference
CDS version:
CPIL version:
SmPC country/version/date: EU Q4W SmPC
v8.0
GRL approval
:
30 January 2022
Name & Date
FTA (13 October 2022)
IMFINZI™
DURVALUMAB CONCENTRATED SOLUTION FOR INFUSION
1
NAME OF THE MEDICINAL PRODUCT
IMFINZI 120 mg Infusion
IMFINZI 500 mg Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of IMFINZI concentrated solution for infusion contains
either 120 mg or 500 mg of
durvalumab.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Sterile, preservative free, clear to opalescent and free from visible
particles, colourless to slightly
yellow, concentrated solution for infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC)
IMFINZI (durvalumab) is indicated for the treatment of patients with
locally advanced,
unresectable NSCLC whose disease has not progressed following
platinum-based chemoradiation
therapy.
DISETUJUI OLEH BPOM: 14/09/2023
EREG10042212200291-92
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SMALL CELL LUNG CANCER (SCLC)
IMFINZI in combination with etoposide and either carboplatin or
cisplatin is indicated for the first-
line treatment of adult patients with extensive-stage small cell lung
cancer (ES-SCLC).
4.2
DOSE AND METHOD OF ADMINISTRATION
IMFINZI is for single use in one patient only. Discard any residue.
Posology
The recommended dose for IMFINZI monotherapy and IMFINZI in
combination with
chemotherapy is presented in Table 1. IMFINZI is administered as an
intravenous infusion over 1
hour.
TABLE 1. RECOMMENDED DOSE OF IMFINZI
INDICATION
RECOMMENDED IMFINZI
DOSE
DURATION OF THERAPY
Locally Advanced NSCLC
10 mg/kg every 2 week