Source: European Medicines Agency (EU) Revision Year: 2018 Publisher: Gedeon Richter Plc., Gyömrői út 19-21., 1103, Budapest, Hungary
Reagila 1.5 mg hard capsules.
Reagila 3 mg hard capsules.
Reagila 4.5 mg hard capsules.
Reagila 6 mg hard capsules.
| Pharmaceutical Form |
|---|
|
Hard capsule. Reagila 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. Reagila 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. Reagila 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. Reagila 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. |
Reagila 1.5 mg hard capsules: Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine.
Reagila 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).
Reagila 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).
Reagila 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 6.1.
| 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 contents: Pregelatinized (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.
Reagila 1.5 mg and Reagila 3 mg hard capsules: Cartons contain 7, 14, 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Reagila 4.5 mg and Reagila 6 mg hard capsules: Cartons contain 21, 28, 30, 49, 56, 60, 84, 90 or 98 hard capsules.
Not all pack sizes may be marketed.
Gedeon Richter Plc., Gyömrői út 19-21., 1103, Budapest, Hungary
EU/1/17/1209/001-040
13 July 2017
| Drug | Countries | |
|---|---|---|
| REAGILA | Austria, Cyprus, Estonia, Spain, Finland, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Romania, Turkey, United Kingdom, South Africa |
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