CIPLA PACLITAXEL Paclitaxel (nanoparticle albumin-bound) 100 mg powder for injection (suspension) vial

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

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Active ingredient:
paclitaxel
Available from:
Cipla Australia Pty Ltd
Authorization status:
Registered
Authorization number:
328529

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Public Summary

Summary for ARTG Entry:

328529

CIPLA PACLITAXELPaclitaxel (nanoparticle albumin-bound) 100 mg powder for injection (suspension) vial

ARTG entry for

Medicine Registered

Sponsor

Cipla Australia Pty Ltd

Postal Address

Level 1 / 132-136 Albert Road, SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

29/10/2020

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 . CIPLA PACLITAXEL Paclitaxel (nanoparticle albumin-bound) 100 mg powder for injection (suspension) vial

Product Type

Single Medicine Product

Effective Date

29/10/2020

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

Metastatic breast cancer: Cipla Paclitaxel is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 50 mL vial

(S4) Prescription Only Medicine

Components

1 . CIPLA PACLITAXEL Paclitaxel (nanoparticle albumin-bound) 100 mg powder for injection (suspension) vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

Nano-paclitaxel injection is a sterile white to yellow lyophilized cake or powder in a 50 mL USP Type I flint glass vial.

Active Ingredients

paclitaxel

100 mg

Other Ingredients (Excipients)

Albumin

N-acetyl-dl-tryptophan

Public Summary

Page 1 of

Produced at 12.01.2021 at 05:16:43 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

sodium octanoate

© 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 05:16:43 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

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