DIACOMIT stiripentol 250 mg powder for oral suspension sachet

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

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Active ingredient:
stiripentol
Available from:
Emerge Health Pty Ltd
Authorization status:
Registered
Authorization number:
281460

Public Summary

Summary for ARTG Entry:

281460

DIACOMIT stiripentol 250 mg powder for oral suspension sachet

ARTG entry for

Medicine Registered

Sponsor

Emerge Health Pty Ltd

Postal Address

Suite 3 / 22 Gillman Street,Hawthorn East, VIC, 3123

Australia

ARTG Start Date

13/09/2019

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. DIACOMIT stiripentol 250 mg powder for oral suspension sachet

Product Type

Single Medicine Product

Effective date

13/09/2019

Permitted Indications

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

DIACOMIT is indicated for adjunctive treatment of generalised tonic-clonic and clonic

seizures associated with severe myoclonic epilepsy in infancy (SMEI, also known as Dravet syndrome) in patients whose seizures are not adequately

controlled with a benzodiazepine (usually clobazam) and valproate.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Other composite

material

36 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

60 sachets

(S4) Prescription Only Medicine

Components

1. DIACOMIT stiripentol 250 mg powder for oral suspension sachet

Dosage Form

Powder, oral

Route of Administration

Oral

Visual Identification

Pale pink powder packaged in paper/Al/PE film composite

Active Ingredients

stiripentol

250 mg

© 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 1 of

Produced at 02.10.2019 at 03:24:18 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

Public Summary

Page 2 of

Produced at 02.10.2019 at 03:24:18 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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