IMATAB imatinib (as mesilate) 400 mg tablet bottle

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

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Active ingredient:
imatinib mesilate
Available from:
Juno Pharmaceuticals Pty Ltd
Authorization status:
Registered
Authorization number:
300067

Public Summary

Summary for ARTG Entry:

300067

IMATAB imatinib (as mesilate) 400 mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Juno Pharmaceuticals Pty Ltd

Postal Address

Level 2 6 Bond Street,South Yarra, VIC, 3141

Australia

ARTG Start Date

29/08/2019

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. IMATAB imatinib (as mesilate) 400 mg tablet bottle

Product Type

Single Medicine Product

Effective date

29/08/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

The proposed Imatinib tablet is indicated for the:,· treatment of patients with chronic myeloid leukaemia (CML),· treatment of adult and paediatric patients

with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy,· treatment of adult

patients with relapsed or refractory Ph+ ALL as monotherapy,· treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD)

associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, where conventional therapies have failed,· treatment of adult

patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed,· treatment of adult patients with hypereosinophilic

syndrome (HES) and/or chronic eosinophilic leukaemia (CEL),· adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma

protuberans (DFSP).

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

36 Months

Store below 25

degrees Celsius

Child resistant closure

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. IMATAB imatinib (as mesilate) 400 mg tablet bottle

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Brownish, oval, biconvex, film coated tablet debossed with "400" on one

side, scoreline on other side and "N" & "I" on either sides of this scoreline

Active Ingredients

imatinib mesilate

477.88 mg

Public Summary

Page 1 of

Produced at 30.08.2019 at 08:15:32 AEST

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

© 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 30.08.2019 at 08:15:32 AEST

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

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