FREORLA

Страна: Индонезия

Език: индонезийски

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

Броя в опаковка:

DUS, 2 BLISTER @ 7 TABLET SALUT SELAPUT

Дата Оторизация:

2023-01-25

Данни за продукта

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