PROMETAX

Main information

  • Trade name:
  • PROMETAX PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PROMETAX PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222605
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222605

PROMETAX PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet

ARTG entry for

Medicine Registered

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 101,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

7/04/2015

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. PROMETAX PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet

Product Type

Single Medicine Product

Effective date

9/06/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

EXELON / PROMETAX is indicated for the treatment of patients with mild, moderate and severe dementia of the Alzheimer's type.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Other composite

material

2 Years

Store below 25

degrees Celsius

Child resistant closure

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

7 transdermal drug delivery systems

(S4) Prescription Only Medicine

30 transdermal drug delivery systems

(S4) Prescription Only Medicine

Components

1. PROMETAX PATCH 15 rivastigmine 13.3mg/24 hours transdermal drug delivery system sachet

Dosage Form

Drug delivery system, transdermal

Route of Administration

Transdermal

Visual Identification

Circular 15 cm2 transdermal drug delivery system, backing layer (beige),

bi-layer adhesive matrix and an oversized rectangular overlapping release

liner with dimples. Patch backing is printed with "CNFU" and "Exelon Patch

15 (rivastigmine)"

Active Ingredients

Rivastigmine

27 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 26.11.2017 at 11:02:35 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

15-5-2018

Prometax (Novartis Europharm Limited)

Prometax (Novartis Europharm Limited)

Prometax (Active substance: Rivastigmine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2996 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/255/T/118

Europe -DG Health and Food Safety