FRAIZERON

البلد: أندونيسيا

اللغة: الإندونيسية

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

العنصر النشط:

SECUKINUMAB

متاح من:

NOVARTIS INDONESIA - Indonesia

INN (الاسم الدولي):

SECUKINUMAB

جرعة:

150 MG/VIAL

الشكل الصيدلاني:

SERBUK INJEKSI

الوحدات في الحزمة:

DUS, 1 VIAL @ 150 MG

المصنعة من قبل:

NOVARTIS PHARMA STEIN A.G., STEIN, SWISS

تاريخ الترخيص:

2017-07-20

خصائص المنتج

Dirilis Badan POM 28 April 2023
_PUBLIC ASSESSMENT REPORT _
FRAIZERON
INFORMASI PRODUK
Nama obat
:
Fraizeron
Bentuk sediaan
:
Serbuk Injeksi
Zat aktif
:
Tiap vial mengandung :
Secukinumab 150 mg
Kemasan
:
Dus, 1 vial @ 150 mg
Pendaftar
:
PT. Novartis Indonesia, Jakarta
Produsen
:
Novartis Pharma Stein AG, Stein, Switzerland untuk Novartis Pharma AG,
Basel, Switzerland
Kategori Registrasi
:
Registrasi produk biologi yang sudah terdaftar dengan indikasi dan
posologi
baru
Indikasi yang
diajukan:
:
_Fraizeron is indicated for the treatment of moderate to severe plaque
psoriasis in _
_patients _
_6 _
_years _
_and _
_older _
_who _
_are _
_candidates _
_for _
_systemic _
_therapy _
_or _
_phototherapy. _
_ _
_Psoriatic arthritis _
_Fraizeron, alone or in combination with methotrexate (MTX), is
indicated for the _
_treatment of active psoriatic arthritis in adult patients when the
response to _
_previous disease-modifying anti-rheumatic drug (DMARD) therapy has
been _
_inadequate. _
_ _
_Axial spondyloarthritis (axSpA) with or without radiographic damage _
_Ankylosing spondylitis (AS) / axSpA with radiographic damage _
_Fraizeron is indicated for the treatment of active ankylosing
spondylitis in adults _
_who have responded inadequately to conventional therapy. _
_ _
_Non-radiographic _
_axial _
_spondyloarthritis _
_(nr-axSpA) _
_/ _
_axSpA _
_without _
_radiographic damage. Fraizeron is indicated for the treatment of
adult patients _
_with active non-radiographic axial spondyloarthritis with objective
signs of _
_inflammation who have responded inadequately to conventional therapy.
_
_ _
_JUVENILE IDIOPATHIC ARTHRITIS (JIA) _
_ENTHESITIS-RELATED ARTHRITIS (ERA) _
_FRAIZERON IS INDICATED FOR THE TREATMENT OF ACTIVE ENTHESITIS-RELATED
ARTHRITIS IN _
_PATIENTS 2 YEARS AND OLDER. _
_ _
_JUVENILE PSORIATIC ARTHRITIS (JPSA) _
_FRAIZERON IS INDICATED FOR THE TREATMENT OF ACTIVE JUVENILE PSORIATIC
ARTHRITIS IN _
_PATIENTS 2 YEARS AND OLDER. _
_ _
_ _
_ _
Posologi yang
diajukan
:
_Dosage regimen and administration _
_Dosage r