MULTIROS glatiramer acetate 20 mg/1mL solution for injection prefilled syringe

Австралия - английский - Department of Health (Therapeutic Goods Administration)

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Активный ингредиент:
glatiramer acetate
Доступна с:
Juno Pharmaceuticals Pty Ltd
Статус Авторизация:
Registered
Количество Авторизация:
303651

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Public Summary

Summary for ARTG Entry:

303651

MULTIROS glatiramer acetate 20 mg/1mL solution for injection prefilled syringe

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

12/11/2020

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 . MULTIROS glatiramer acetate 20 mg/1mL solution for injection prefilled syringe

Product Type

Single Medicine Product

Effective Date

12/11/2020

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

Reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis.,Treatment of patients with a single clinical event suggestive

of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1 . MULTIROS glatiramer acetate 20 mg/1mL solution for injection prefilled syringe

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

Clear solution in a clear, colourless glass syringe equipped with needle covered by a needle shield, stopper and piston rod.

Active Ingredients

glatiramer acetate

20 mg/mL

Other Ingredients (Excipients)

Public Summary

Page 1 of

Produced at 14.01.2021 at 07:48:59 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

mannitol

water for injections

© 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 14.01.2021 at 07:48:59 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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