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EXJADE Dispersible tablet (2019)

Active ingredients: Deferasirox

Product Name and Form

EXJADE 125 mg dispersible tablets.

EXJADE 250 mg dispersible tablets.

EXJADE 500 mg dispersible tablets.

Pharmaceutical form

Dispersible tablet.

EXJADE 125 mg dispersible tablets: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other). Approximate tablet dimensions 12 mm x 3.6 mm.

EXJADE 250 mg dispersible tablets: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other). Approximate tablet dimensions 15 mm x 4.7 mm.

EXJADE 500 mg dispersible tablets: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other). Approximate tablet dimensions 20 mm x 5.6 mm

Qualitative and Quantitative Composition

EXJADE 125 mg dispersible tablets: Each dispersible tablet contains 125 mg deferasirox.

Excipient with known effect: Each dispersible tablet contains 136 mg lactose.

EXJADE 250 mg dispersible tablets: Each dispersible tablet contains 250 mg deferasirox.

Excipient with known effect: Each dispersible tablet contains 272 mg lactose.

EXJADE 500 mg dispersible tablets: Each dispersible tablet contains 500 mg deferasirox.

Excipient with known effect: Each dispersible tablet contains 544 mg lactose.

For the full list of excipients, see section 6.1.

Chemical substance
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

Lactose monohydrate
Crospovidone type A
Cellulose, microcrystalline
Povidone
Sodium laurilsulfate
Silica, colloidal anhydrous
Magnesium stearate

Pack sizes and Marketing

PVC/PE/PVDC/Aluminium blisters.

EXJADE 125 mg dispersible tablets: Packs containing 28, 84 or 252 dispersible tablets.

EXJADE 250 mg dispersible tablets: Packs containing 28, 84 or 252 dispersible tablets.

EXJADE 500 mg dispersible tablets: Unit packs containing 28, 84 or 252 dispersible tablets and multipacks containing 294 (3 packs of 98) dispersible tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

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

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

Marketing authorization number:

EXJADE 125 mg dispersible tablets:

EU/1/06/356/001
EU/1/06/356/002
EU/1/06/356/007

EXJADE 250 mg dispersible tablets:

EU/1/06/356/003
EU/1/06/356/004
EU/1/06/356/008

EXJADE 500 mg dispersible tablets:

EU/1/06/356/005
EU/1/06/356/006
EU/1/06/356/009
EU/1/06/356/010