LATUDA Film-coated tablet Ref.[9812] Active ingredients: Lurasidone

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A., Viale Amelia 70, 00181, Rome Italy

Product name and form

Latuda 18.5 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

White to off-white, film-coated round tablets of 6 mm debossed with ‘LA’.

Qualitative and quantitative composition

Each film-coated tablet contains lurasidone hydrochloride equivalent to18.6 mg lurasidone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Lurasidone

Lurasidone is a selective blocking agent of dopamine and monoamine effects indicated for the treatment of schizophrenia. Lurasidone binds strongly to dopaminergic D2- and to serotonergic 5-HT2A and 5-HT7 receptors. Lurasidone does not bind to histaminergic or muscarinic receptors.

List of Excipients

Core:

Mannitol (E421)
Starch, pregelatinised
Croscarmellose sodium (E468)
Hypromellose 2910 (E464)
Magnesium stearate (E470b)

Tablet coating:

Hypromellose 2910 (E464)
Titanium dioxide (E171)
Macrogol 8000
Carnauba wax (E903)

Pack sizes and marketing

Cartons contain 14 × 1, 28 × 1, 30 × 1, 56 × 1, 60 × 1, 90 × 1 or 98 × 1 tablets in aluminium/aluminium perforated unit dose blisters.

Not all pack sizes may be marketed.

Marketing authorization holder

Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A., Viale Amelia 70, 00181, Rome – Italy

Marketing authorization dates and numbers

EU/1/14/913/001-007

Date of first authorisation: 21 March 2014
Date of latest renewal: 14 November 2018

Drugs

Drug Countries
LATUDA Austria, Australia, Brazil, Canada, Estonia, Spain, Finland, Hong Kong, Ireland, Japan, Lithuania, Netherlands, Poland, Romania, Singapore, United Kingdom, United States

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