Quốc gia: Indonesia
Ngôn ngữ: Tiếng Indonesia
Nguồn: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 2 BLISTER @ 7 TABLET SALUT SELAPUT
2023-01-25
PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Abrocitinib Trade Name: FREORLA CDS Effective Date: June 04, 2021 Supersedes: NA 1. NAME OF THE MEDICINAL PRODUCT FREORLA 50 mg film-coated tablets FREORLA 100 mg film-coated tablets FREORLA 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION FREORLA 50 mg film-coated tablets Each film-coated tablet contains 50 mg abrocitinib FREORLA 100 mg film-coated tablets Each film-coated tablet contains 100 mg abrocitinib FREORLA 200 mg film-coated tablets Each film-coated tablet contains 200 mg abrocitinib Excipients with known effects Each FREORLA 50 mg film-coated tablet contains 1.365 mg of lactose monohydrate. Each FREORLA 100 mg film-coated tablet contains 2.73 mg of lactose monohydrate. Each FREORLA 200 mg film-coated tablet contains 5.46 mg of lactose monohydrate. For a full list of excipients, see Section 6.1 Structure of abrocitinib: DISETUJUI OLEH BPOM: 11/01/2023 ID: EREG10024112100471 EREG10024112100473 EREG10024112100475 3. PHARMACEUTICAL FORM Film-coated tablet. FREORLA 50 mg film-coated tablets Pink, oval tablet 10.50 mm long and 4.75 mm wide, debossed with “PFE” on one side and “ABR 50” on the other. FREORLA 100 mg film-coated tablets Pink, round tablet 9.00 mm in diameter, debossed with “PFE” on one side and “ABR 100” on the other. FREORLA 200 mg film-coated tablets Pink, oval tablet 18.42 mm long and 8.00 mm wide debossed with “PFE” on one side and “ABR 200” on the other. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS FREORLA is indicated for the treatment of adult patients with age 18 years or older with moderate-to-severe atopic dermatitis, including the relief of pruritus, who have had an inadequate response to prescribed topical therapy or for whom these treatments are not advisable. FREORLA can be used with or without medicated topical therapies for atopic dermatitis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and supervised by a healthcare professional experiences Đọc toàn bộ tài liệu