CUPRIOR Film-coated tablet Ref.[9243] Active ingredients: Trientine

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: gmp-orphan SA, Pépinière Paris Santé Cochin, 27-29 rue du Faubourg Saint-Jacques, 75014, Paris, France

Product name and form

Cuprior 150 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet (tablet).

Yellow, 16 mm x 8 mm oblong film-coated tablet with a score line on each side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains trientine tetrahydrochloride equivalent to 150 mg trientine.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Trientine

Trientine is a copper-chelating agent whose principal mechanism of action is to eliminate absorbed copper from the body by forming a stable complex that is then eliminated through urinary excretion. Trientine may also chelate copper in the intestinal tract and so inhibit copper absorption.

List of Excipients

Tablet core:

Mannitol
Colloidal anhydrous silica
Glycerol dibehenate

Tablet film-coating:

Polyvinyl alcohol
Talc
Titanium dioxide (E171)
Glycerol monocaprylocaprate (Type I)
Iron oxide yellow (E172)
Sodium laurilsulfate

Pack sizes and marketing

OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets.

Pack size: 72 or 96 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

gmp-orphan SA, Pépinière Paris Santé Cochin, 27-29 rue du Faubourg Saint-Jacques, 75014, Paris, France

Marketing authorization dates and numbers

EU/1/17/1199/001

Date of first authorisation: 5 September 2017

Drugs

Drug Countries
CUPRIOR Austria, Estonia, Finland, France, Ireland, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom

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