EXJADE Granules in sachet Ref.[8599] Active ingredients: Deferasirox

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Product name and form

EXJADE 90 mg granules in sachet.

EXJADE 180 mg granules in sachet.

EXJADE 360 mg granules in sachet.

Pharmaceutical Form

Granules in sachet (granules).

White to almost white granules.

Qualitative and quantitative composition

EXJADE 90 mg granules: Each sachet contains 90 mg deferasirox.

EXJADE 180 mg granules: Each sachet contains 180 mg deferasirox.

EXJADE 360 mg granules: Each sachet contains 360 mg deferasirox.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Deferasirox

Deferasirox is an orally active chelator that is highly selective for iron (III). It is a tridentate ligand that binds iron with high affinity in a 2:1 ratio. Deferasirox promotes excretion of iron, primarily in the faeces.

List of Excipients

Cellulose, microcrystalline
Crospovidone
Povidone
Magnesium stearate
Silica, colloidal anhydrous
Poloxamer

Pack sizes and marketing

Sachets of polyethylene terephthalate (PET)/Aluminium/polyethylene (PE) foil.

Unit packs containing 30 sachets.

Marketing authorization holder

Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

Marketing authorization dates and numbers

EXJADE 90 mg granules: EU/1/06/356/020
EXJADE 180 mg granules: EU/1/06/356/021
EXJADE 360 mg granules: EU/1/06/356/022

Date of first authorisation: 28 August 2006
Date of latest renewal: 18 April 2016

Drugs

Drug Countries
EXJADE Austria, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

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