TAGRISSO

Riik: Indoneesia

keel: indoneesia

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

Toimeaine:

OSIMERTINIB MESILATE

Saadav alates:

ASTRAZENECA INDONESIA - Indonesia

INN (Rahvusvaheline Nimetus):

OSIMERTINIB MESILATE

Annus:

40 MG

Ravimvorm:

TABLET SALUT SELAPUT

Ühikuid pakis:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Valmistatud:

ASTRAZENECA Pharmaceuticals - Sweden

Loa andmise kuupäev:

2018-05-24

Toote omadused

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TAGRISSO
_Osimertinib _
FILM-COATED TABLET
1.
NAME OF THE MEDICINAL PRODUCT
TAGRISSO 80 mg film-coated tablets
TAGRISSO 40 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 80 mg tablet contains a dose of 80 mg osimertinib (as mesylate).
Each 40 mg tablet contains a dose of 40 mg osimertinib (as mesylate).
For excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
The TAGRISSO 80 mg tablet is a beige, 7.25 x 14.5 mm, oval, biconvex
tablet, debossed with “AZ”
and “80” on one side and plain on the reverse.
The TAGRISSO 40 mg tablet is a beige, 9 mm, round, biconvex tablet,
debossed with “AZ” and “40”
on one side and plain on the reverse.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TAGRISSO (osimertinib) is indicated for:
•
the first-line treatment of patients with locally advanced or
metastatic non-small cell lung
cancer (NSCLC) whose tumours have epidermal growth factor receptor
(EGFR) exon 19
deletions or exon 21 (L858R) substitution mutations.
•
the treatment of adult patients with locally advanced or metastatic
epidermal growth factor
receptor (EGFR) T790M mutation-positive non-small-cell lung cancer
(NSCLC) who have
progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with TAGRISSO should be initiated by a physician experienced
in the use of anticancer
therapies.
When considering the use of TAGRISSO, EGFR mutation status in tumour
or plasma specimens
DISETUJUI OLEH BPOM: 30/06/2021
ID: EREG100422VR12100032
EREG100422VR12100037
EREG100422VR12100040
EREG100422VR12100041
Page 2 of 32
should be determined using a validated test method (see section 4.4)
for:
•
exon 19 deletions or exon 21 (L858R) substitution mutations (for
first-line treatment)
•
T790M mutations (following progression on or after EGFR TKI therapy).
Posology
The recommended dose of TAGRISSO is 80 mg osimertinib once a day until
disease progression or
unacceptable toxicity.
Missed dose
If a dose of