Source: Health Sciences Authority (SG) Publisher: <u>Under license from:</u> Gedeon Richter Plc., Budapest, Hungary <u>Manufactured by:</u> Gedeon Richter Plc., Budapest, Hungary <u>Product Registrant:</u> Mitsubishi Tanabe Pharma Singapore Pte. Ltd., ...
Symvenu.
| 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. 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 black ink. The capsules are filled with white to yellowish white powder mixture. |
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 (E129).
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 (E129).
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 (E129).
For the full list of excipients, see section 5.1.
| Active Ingredient | Description | |
|---|---|---|
| Cariprazine |
Cariprazine is indicated for the treatment of schizophrenia in adult patients. The mechanism of action of cariprazine is not fully known. However the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at dopamine D3, D2 (Ki values of 0.085-0.3 nM versus 0.49-0.71 nM respectively) and serotonin 5-HT1A receptors (Ki values of 1.4-2.6 nM), and antagonist activity at serotonin 5-HT2B, 5-HT2A and histamine H1 receptors (Ki values of 0.58-1.1 nM, 18.8 nM and 23.3 nM, respectively). |
| List of Excipients |
|---|
Capsule contentsPregelatinized (maize) starch Capsule shell (1.5 mg capsule): Titanium dioxide (E171) Capsule shell (3 mg capsule): Allura red AC (E129) Capsule shell (4.5 mg capsule): Allura red AC (E129) Capsule shell (6 mg capsule): Brilliant blue FCF (E133) Printing ink (black: 1.5 mg, 3 mg and 6 mg capsules): Shellac Printing ink (white: 4.5 mg capsule): Shellac |
Transparent hard PVC/PE/PVDC blister heat-sealed with hard aluminium foil backing packed in folded carton box. Cartons contain 28 hard capsules.
Under license from: Gedeon Richter Plc., Budapest, Hungary
Manufactured by: Gedeon Richter Plc., Budapest, Hungary
Product Registrant: Mitsubishi Tanabe Pharma Singapore Pte. Ltd., Absorption, Singapore
Date of Package Insert: 09 June, 2020 (version 2.0)
| Drug | Countries | |
|---|---|---|
| SYMVENU | Singapore |
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