FERRIPROX Film-coated tablet Ref.[9509] Active ingredients: Deferiprone

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy

Product name and form

Ferriprox 500 mg film-coated tablets.
Ferriprox 1000 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Ferriprox 500 mg film-coated tablets: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “500” on one side, plain on the other. The tablet is scored. The tablet can be divided into equal halves.

Ferriprox 1000 mg film-coated tablets: White to off-white, capsule-shaped, film-coated tablets imprinted “APO” bisect “1000” on one side, plain on the other. The tablet is scored. The tablet can be divided into equal halves.

Qualitative and quantitative composition

Ferriprox 500 mg film-coated tablets: Each tablet contains 500 mg deferiprone.

Ferriprox 1000 mg film-coated tablets: Each tablet contains 1000 mg deferiprone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Deferiprone

Deferiprone is a bidentate ligand which binds iron in a 3:1 molar ratio. Deferiprone monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.
List of Excipients

Ferriprox 500 mg film-coated tablets

Tablet core:

Microcrystalline cellulose
Magnesium stearate
Colloidal silicon dioxide

Coating:

Hypromellose
Macrogol
Titanium dioxide

Ferriprox 1000 mg film-coated tablets

Tablet core:

Methylcellulose USP A15LV
Crospovidone
Magnesium stearate

Coating:

Hypromellose 2910 USP/EP
Hydroxypropyl cellulose
Macrogol
Titanium dioxide

Pack sizes and marketing

Ferriprox 500 mg film-coated tablets: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap. Pack size of 100 tablets.

Ferriprox 1000 mg film-coated tablets: High density polyethylene (HDPE) bottle with a child resistant polypropylene cap and a desiccant. Pack size of 50 tablets.

Marketing authorization holder

Chiesi Farmaceutici S.p.A., Via Palermo 26/A, 43122, Parma, Italy

Marketing authorization dates and numbers

Ferriprox 500 mg film-coated tablets: EU/1/99/108/001
Ferriprox 1000 mg film-coated tablets: EU/1/99/108/004

Date of first authorisation: 25 August 1999
Date of latest renewal: 21 September 2009

Drugs

Drug Countries
FERRIPROX Austria, Australia, Brazil, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States
 
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