RXULTI Film-coated tablet Ref.[7627] Active ingredients: Brexpiprazole

Source: European Medicines Agency (EU)  Revision Year: 2025  Publisher: Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

Product name and form

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.

Qualitative and quantitative composition

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 approximately 45.8 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 approximately 45.5 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 approximately 45 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 approximately 44.1 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 approximately 43.1 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 approximately 42.2 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient

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
Maize starch
Microcrystalline cellulose
Low-substituted hydroxypropylcellulose
Hydroxypropylcellulose
Magnesium stearate
Purified water

Tablet coat:

Hypromellose (E464)
Talc (E553b)
Titanium dioxide (E171)

RXULTI 0.25 mg film-coated tablets

Iron oxide (E172) (yellow, red, black)

RXULTI 0.5 mg film-coated tablets

Iron oxide (E172) (yellow, red)

RXULTI 1 mg film-coated tablets

Iron oxide (E172) (yellow)

RXULTI 2 mg film-coated tablets

Iron oxide (E172) (yellow, black)

RXULTI 3 mg film-coated tablets

Iron oxide (E172) (red, black)

Pack sizes and marketing

RXULTI 0.25 mg and 0.5 mg film-coated tablets: 28 film-coated tablets in Aluminium/PVC blisters.

RXULTI 1 mg film-coated tablets: 10, 28 or 56 film-coated tablets in Aluminium/PVC blisters.

RXULTI 2 mg, 3 mg and 4 mg film-coated tablets: 28 or 56 film-coated tablets in Aluminium/PVC blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands

Marketing authorization dates and numbers

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)
EU/1/18/1294/008 (56 film-coated tablets)

RXULTI 2 mg film-coated tablets:

EU/1/18/1294/005 (28 film-coated tablets)
EU/1/18/1294/009 (56 film-coated tablets)

RXULTI 3 mg film-coated tablets:

EU/1/18/1294/006 (28 film-coated tablets)
EU/1/18/1294/010 (56 film-coated tablets)

RXULTI 4 mg film-coated tablets:

EU/1/18/1294/007 (28 film-coated tablets)
EU/1/18/1294/011 (56 film-coated tablets)

Date of first authorisation: 26 July 2018
Date of latest renewal: 26 May 2023

Drugs

Drug Countries
RXULTI Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Netherlands, Poland
 
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