Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
RXULTI 0.25 mg film-coated tablets.
RXULTI 0.5 mg film-coated tablets.
RXULTI 1 mg film-coated tablets.
RXULTI 2 mg film-coated tablets.
RXULTI 3 mg film-coated tablets.
RXULTI 4 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet. RXULTI 0.25 mg film-coated tablets: Light brown, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.25 on one side. RXULTI 0.5 mg film-coated tablets: Light orange, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.5 on one side. RXULTI 1 mg film-coated tablets: Light yellow, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 1 on one side. RXULTI 2 mg film-coated tablets: Light green, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 2 on one side. RXULTI 3 mg film-coated tablets: Light purple, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 3 on one side. RXULTI 4 mg film-coated tablets: White, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 4 one side. |
RXULTI 0.25 mg film-coated tablets: Each film-coated tablet contains 0.25 mg brexpiprazole.
Excipient with known effect: Each film-coated tablet contains 48.2 mg lactose (as monohydrate).
RXULTI 0.5 mg film-coated tablets: Each film-coated tablet contains 0.5 mg brexpiprazole.
Excipient with known effect: Each film-coated tablet contains 47.9 mg lactose (as monohydrate).
RXULTI 1 mg film-coated tablets: Each film-coated tablet contains 1 mg brexpiprazole.
Excipient with known effect: Each film-coated tablet contains 47.4 mg lactose (as monohydrate).
RXULTI 2 mg film-coated tablets: Each film-coated tablet contains 2 mg brexpiprazole.
Excipient with known effect: Each film-coated tablet contains 46.4 mg lactose (as monohydrate).
RXULTI 3 mg film-coated tablets: Each film-coated tablet contains 3 mg brexpiprazole.
Excipient with known effect: Each film-coated tablet contains 45.4 mg lactose (as monohydrate).
RXULTI 4 mg film-coated tablets: Each film-coated tablet contains 4 mg brexpiprazole.
Excipient with known effect: Each film-coated tablet contains 44.4 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Brexpiprazole |
Brexpiprazole is an atypical antipsychotic agent. The pharmacology of brexpiprazole is believed to be mediated by a modulatory activity at the serotonin and dopamine systems that combines partial agonist activity at serotonergic 5-HT1A and at dopaminergic D2 receptors with antagonist activity at serotonergic 5-HT2A receptors, with similar high affinities at all of these receptors. |
| List of Excipients |
|---|
|
Tablet core: Lactose monohydrate Tablet coat: Hypromellose |
RXULTI 0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg film-coated tablets: 28 film-coated tablets in Aluminium/PVC blisters.
RXULTI 1 mg film-coated tablets: 10 or 28 film-coated tablets in Aluminium/PVC blisters.
Not all pack sizes may be marketed
Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
RXULTI 0.25 mg film-coated tablets: EU/1/18/1294/001 (28 film-coated tablets)
RXULTI 0.5 mg film-coated tablets: EU/1/18/1294/002 (28 film-coated tablets)
RXULTI 1 mg film-coated tablets: EU/1/18/1294/003 (10 film-coated tablets), EU/1/18/1294/004 (28 film-coated tablets)
RXULTI 2 mg film-coated tablets: EU/1/18/1294/005 (28 film-coated tablets)
RXULTI 3 mg film-coated tablets: EU/1/18/1294/006 (28 film-coated tablets)
RXULTI 4 mg film-coated tablets: EU/1/18/1294/007 (28 film-coated tablets)
Date of first authorisation: 26 July 2018
| Drug | Countries | |
|---|---|---|
| RXULTI | Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland |
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