Ország: Indonézia
Nyelv: indonéz
Forrás: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
CARIPRAZINE HYDROCHLORIDE
MITSUBISHI TANABE PHARMA INDONESIA - Indonesia
CARIPRAZINE HYDROCHLORIDE
1.635 MG
KAPSUL
DUS, 4 BLISTER @ 7 KAPSUL KERAS
GEDEON RICHTER PLC. - Hungary
2021-07-22
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 EREG10002812200033 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 Olvassa el a teljes dokumentumot