SYMVENU 1.5 MG

Land: Indonesien

Sprog: indonesisk

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

Aktiv bestanddel:

CARIPRAZINE HYDROCHLORIDE

Tilgængelig fra:

MITSUBISHI TANABE PHARMA INDONESIA - Indonesia

INN (International Name):

CARIPRAZINE HYDROCHLORIDE

Dosering:

1.635 MG

Lægemiddelform:

KAPSUL

Enheder i pakken:

DUS, 4 BLISTER @ 7 KAPSUL KERAS

Fremstillet af:

GEDEON RICHTER PLC. - Hungary

Autorisation dato:

2021-07-22

Produktets egenskaber

SYMVENU
®
cariprazine hydrochloride
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Symvenu
®
1.5 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
1.5 mg cariprazine.
Symvenu
®
3 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
3 mg cariprazine.
Excipients with known effect
Each hard capsule contains 0.0003 mg Allura red AC (E 129).
Symvenu
®
4.5 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
4.5 mg cariprazine.
Excipients with known effect
Each hard capsule contains 0.0008 mg Allura red AC (E 129).
Symvenu
®
6 mg hard capsules
Each hard capsule contains cariprazine hydrochloride corresponding to
6 mg cariprazine.
Excipients with known effect
Each hard capsule contains 0.0096 mg Allura red AC (E 129).
For the full list of excipients, see section 5.1.
2.
PHARMACEUTICAL FORM
Hard capsule
Symvenu
®
1.5 mg hard capsules
‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule
with white opaque cap and white
opaque body imprinted with “GR 1.5” on the capsule body with black
ink. The capsules are filled with
white to yellowish white powder mixture.
Symvenu
®
3 mg hard capsules
‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule
with green opaque cap and white
opaque body imprinted with “GR 3” on the capsule body with black
ink. The capsules are filled with
white to yellowish white powder mixture.
DISETUJUI OLEH BPOM: 08/02/2023
EREG10002812200030
EREG10002812200031
EREG10002812200032
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Symvenu
®
4.5 mg hard capsules
‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule
with green opaque cap and green
opaque body imprinted with “GR 4.5” on the capsule body with white
ink. The capsules are filled with
white to yellowish white powder mixture.
Symvenu
®
6 mg hard capsules
‘Size 3’ (approximately 15.9 mm in length) hard gelatin capsule
with purple opaque cap and white
opaque body imprinted with “GR 6” on the capsule body with bl