Sumatriptan 100 mg tablet bulk

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

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Active ingredient:
sumatriptan succinate
Available from:
Alphapharm Pty Ltd
Authorization status:
Listed (Export Only)
Authorization number:
346507

Read the complete document

Public Summary

Summary for ARTG Entry:

346507

Sumatriptan 100 mg tablet bulk

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Alphapharm Pty Ltd

Postal Address

PO Box R1462, ROYAL EXCHANGE, NSW, 1225

Australia

ARTG Start Date

23/10/2020

Product Category

Medicine

Status

Active

Approval Area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods on

the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to substantiate and

support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription Medicines Authorisation

Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i) each

overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each overseas

importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1 . Sumatriptan 100 mg tablet bulk

Product Type

Single Medicine Product

Effective Date

23/10/2020

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

No Specific Indications included on Record

Warnings

No Warnings included on Record

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bulk Container

Not recorded

Not recorded

Not recorded

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1 .

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

A white film-coated, round, biconvex, bevelled edge tablet debossed with M over S12 on one side and blank on the other

side

Active Ingredients

sumatriptan succinate

140 mg

Other Ingredients (Excipients)

Public Summary

Page 1 of

Produced at 12.01.2021 at 12:06:16 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

croscarmellose sodium

hypromellose

lactose monohydrate

macrogol 400

macrogol 8000

magnesium stearate

microcrystalline cellulose

polydextrose

povidone

silicon dioxide

sodium lauryl sulfate

titanium dioxide

triacetin

© 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 12:06:16 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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