EXFORGE 5/80

Страна: Индонезия

Язык: индонезийский

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

Активный ингредиент:

VALSARTAN, AMLODIPINE BESILATE

Доступна с:

NOVARTIS INDONESIA - Indonesia

ИНН (Международная Имя):

VALSARTAN, AMLODIPINE BESILATE

дозировка:

80.00 MG /6.94 MG

Фармацевтическая форма:

TABLET SALUT SELAPUT

Штук в упаковке:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Производитель:

SIEGFRIED BARBERA, S.L. - Spain

Дата Авторизация:

2021-09-09

Характеристики продукта

EXFORGE
®
(AMLODIPINE/VALSARTAN)
FILM-COATED TABLETS 5 MG/80 MG, 5 MG/160 MG, AND 10 MG/160 MG
LEAFLET
DISETUJUI OLEH BPOM: 10/08/2021
EREG100005VR12100109
EREG100005VR12100110
EREG100005VR12100111
TRADE NAME
EXFORGE
®
5 mg/80 mg, 5 mg/160 mg and 10 mg/160 mg film-coated tablets.
DESCRIPTION AND COMPOSITION
Active substances:
Amlodipine besylate: 3-Ethyl-5-methyl
(±)-2-[(2-minoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-
6-methyl-3,5-pyridinedicarboxylate, mono-benzenesulphonate.
Valsartan: (
_S_
)-N-valeryl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-valine.
Three strengths are available. One tablet of Exforge contains:
•
5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan,
dark yellow, round shaped
film-coated tablet with bevelled edges, debossed with “NVR” on one
side and “NV” on the
reverse side.
_ _
•
5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan,
dark yellow, ovaloid
shaped film-coated tablet with bevelled edges, debossed with “NVR”
on one side and “ECE” on
the reverse side.
_ _
•
10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan,
light yellow, ovaloid
shaped film-coated tablet with bevelled edges, debossed with “NVR”
on one side and “UIC” on
the reverse side.
EXCIPIENTS
Exforge 5/80 mg: Cellulose microcrystalline; crospovidone; silica,
colloidal anhydrous; magnesium
stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171),
iron oxide, yellow (E172 )
Exforge 5/160 mg: Cellulose microcrystalline; crospovidone; silica,
colloidal anhydrous; magnesium
stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171),
iron oxide, yellow (E172)
Exforge 10/160 mg: Cellulose microcrystalline; crospovidone; silica,
colloidal anhydrous, magnesium
stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171),
iron oxide, yellow (E172), iron
oxide, red (E172 )
PHARMACEUTICAL FORM
Film-coated tablets.
DISETUJUI OLEH BPOM: 10/08/2021
EREG100005VR12100109
EREG100005VR12100110
EREG100005VR12100111
INDICATIONS