EXJADE Film-coated tablet Ref.[8600] 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 film-coated tablets.

EXJADE 180 mg film-coated tablets.

EXJADE 360 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

EXJADE 90 mg film-coated tablets: Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other). Approximate tablet dimensions 10.7 mm x 4.2 mm.

EXJADE 180 mg film-coated tablets: Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 180 on the other). Approximate tablet dimensions 14 mm x 5.5 mm.

EXJADE 360 mg film-coated tablets: Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 360 on the other). Approximate tablet dimensions 17 mm x 6.7 mm.

Qualitative and quantitative composition

EXJADE 90 mg film-coated tablets: Each film-coated tablet contains 90 mg deferasirox.

EXJADE 180 mg film-coated tablets: Each film-coated tablet contains 180 mg deferasirox.

EXJADE 360 mg film-coated tablets: Each film-coated tablet 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

Tablet core:

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

Coating material:

Hypromellose
Titanium dioxide (E171)
Macrogol (4000)
Talc
Indigo carmine aluminium lake (E132)

Pack sizes and marketing

PVC/PVDC/Aluminium blisters.

Unit packs containing 30 or 90 film-coated tablets or multipacks containing 300 (10 packs of 30) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

EXJADE 90 mg film-coated tablets:

EU/1/06/356/011
EU/1/06/356/012
EU/1/06/356/013

EXJADE 180 mg film-coated tablets:

EU/1/06/356/014
EU/1/06/356/015
EU/1/06/356/016

EXJADE 360 mg film-coated tablets:

EU/1/06/356/017
EU/1/06/356/018
EU/1/06/356/019

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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