DASNIB 140

Valsts: Indonēzija

Valoda: indonēziešu

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

Vienības iepakojumā:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Autorizācija datums:

2022-11-17

Produkta apraksts

DASNIB 20
DASNIB 50
DASNIB 70
DASNIB 80
DASNIB 100
DASNIB 140
DASATINIB
Film-coated tablets 20 mg
Film-coated tablets 50 mg
Film-coated tablets 70 mg
Film-coated tablets 80 mg
Film-coated tablets 100 mg
Film-coated tablets 140 mg
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DASNIB 20 mg film-coated tablets
Each film-coated tablet contains 20 mg dasatinib (as monohydrate).
DASNIB 50 mg film-coated tablets
Each film-coated tablet contains 50 mg dasatinib (as monohydrate).
DASNIB 70 mg film-coated tablets
Each film-coated tablet contains 70 mg dasatinib (as monohydrate).
DASNIB 80 mg film-coated tablets
Each film-coated tablet contains 80 mg dasatinib (as monohydrate).
DASNIB 100 mg film-coated tablets
Each film-coated tablet contains 100 mg dasatinib (as monohydrate).
DASNIB 140 mg film-coated tablets
Each film-coated tablet contains 140 mg dasatinib (as monohydrate).
For the full list of excipients, see section 5.1 List of excipients
2.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
DASNIB 20 mg film-coated tablets:
White to off-white, biconvex, round film-coated tablet with a diameter
of approximately 6 mm, with D7SB debossed
on one side and 20 on the other side
DASNIB 50 mg film-coated tablets:
White to off-white, biconvex, oval film-coated tablet with a length of
approximately 11 mm and a width of
approximately 6 mm, with D7SB debossed on one side and 50 on the other
side
DASNIB 70 mg film-coated tablets:
White to off-white, biconvex, round film-coated tablet with a diameter
of approximately 9 mm, with D7SB debossed
on one side and 70 on the other side
DASNIB 80 mg film-coated tablets:
White to off-white, biconvex, triangular film-coated tablet with a
length of approximately 10 mm and a width of
approximately 11 mm, with D7SB debossed one side and 80 on the other
side
DISETUJUI BPOM 7 NOVEMBER 2022
EREG10019112100115;
EREG10019112100121-23;
EREG10019112100125-26
DASNIB 100 mg film-coated tablets:
White to off-white, biconvex, oval film-coated tablet with a length of
approximately 15 mm and a width of
approxima