JADELEM deferasirox 360 mg film-coated tablet blister pack

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:
deferasirox
Available from:
Alembic Pharmaceuticals Australia Pty Ltd
Authorization status:
Registered
Authorization number:
326667

Read the complete document

Public Summary

Summary for ARTG Entry:

326667

JADELEM deferasirox 360 mg film-coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Alembic Pharmaceuticals Australia Pty Ltd

Postal Address

Level 2 108 Power Street, HAWTHORN, VIC, 3122

Australia

ARTG Start Date

16/11/2020

Product Category

Medicine

Status

Active

Approval Area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods Under

Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered or

Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1 . JADELEM deferasirox 360 mg film-coated tablet blister pack

Product Type

Single Medicine Product

Effective Date

16/11/2020

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older.

JADELEM is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine

therapy or in whom desferrioxamine has proven ineffective.,JADELEM is also indicated for the treatment of chronic iron overload in patients with

non-transfusion- dependent thalassemia syndromes aged 10 years and older.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1 . JADELEM deferasirox 360 mg film-coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Dark blue, oval, biconvex, film-coated tablet with beveled edges, debossed with "L" on one side and "665" on the other side.

Approximately 17 mm in length and approximately 7 mm in width.

Active Ingredients

Public Summary

Page 1 of

Produced at 12.01.2021 at 07:49:57 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

deferasirox

360 mg

Other Ingredients (Excipients)

colloidal anhydrous silica

crospovidone

hypromellose

indigo carmine aluminium lake

macrogol 4000

magnesium stearate

microcrystalline cellulose

poloxamer

povidone

purified talc

sodium starch glycollate type A

titanium dioxide

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 12.01.2021 at 07:49:57 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Similar products

Search alerts related to this product

Share this information