Sunitinib Sandoz sunitinib 37.5 mg capsule blister

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

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Active ingredient:
sunitinib
Available from:
Sandoz Pty Ltd
Authorization status:
Registered
Authorization number:
318074

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Public Summary

Summary for ARTG Entry:

318074

Sunitinib Sandoz sunitinib 37.5 mg capsule blister

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road, Macquarie Park, NSW, 2113

Australia

ARTG Start Date

26/11/2020

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 . Sunitinib Sandoz sunitinib 37.5 mg capsule blister

Product Type

Single Medicine Product

Effective Date

26/11/2020

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

· treatment of advanced renal cell carcinoma (RCC),· treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to

resistance or intolerance,· treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET).

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

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

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 . Sunitinib Sandoz sunitinib 37.5 mg capsule blister

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

Gelatin capsules with yellow cap and yellow body, printed with black ink 37.5 mg on the body and containing yellow to

orange granules.

Active Ingredients

sunitinib

37.5 mg

Public Summary

Page 1 of

Produced at 13.01.2021 at 08:57:01 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

Other Ingredients (Excipients)

butan-1-ol

croscarmellose sodium

ethanol absolute

ethanol

Gelatin

iron oxide black

iron oxide yellow

isopropyl alcohol

magnesium stearate

mannitol

microcrystalline cellulose

povidone

propylene glycol

purified water

Shellac

strong ammonia solution

sulfuric acid

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 13.01.2021 at 08:57:01 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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