Страна: Індонезія
мова: індонезійська
Джерело: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SECUKINUMAB
NOVARTIS INDONESIA - Indonesia
SECUKINUMAB
150 MG
SERBUK INJEKSI
DUS, 1 VIAL @ 150 MG
NOVARTIS PHARMA STEIN AG - Switzerland
2022-04-06
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 Прочитайте повний документ