RIVASTIGMINE-DRLA rivastigmine (as hydrogen tartrate) 3 mg capsule blister pack

Main information

  • Trade name:
  • RIVASTIGMINE-DRLA rivastigmine (as hydrogen tartrate) 3 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RIVASTIGMINE-DRLA rivastigmine (as hydrogen tartrate) 3 mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 177398
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

177398

RIVASTIGMINE-DRLA rivastigmine (as hydrogen tartrate) 3 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Dr Reddys Laboratories Australia Pty Ltd

Postal Address

Level 9 / 492 St Kilda Road,MELBOURNE, VIC, 3004

Australia

ARTG Start Date

24/09/2012

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. RIVASTIGMINE-DRLA rivastigmine (as hydrogen tartrate) 3 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

24/09/2012

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

RIVASTIGMINE is indicated for the treatment of patients with mild to moderately severe dementia of the Alzheimer's type.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Blister Pack

Al/Al

2 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. RIVASTIGMINE-DRLA rivastigmine (as hydrogen tartrate) 3 mg capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

White to off-white powder filled in size 2 hard gelatin capsules, light orange

opaque colour cap, light orange opaque colour body, imprinted with 'RV'

over '3' on body with red ink

Active Ingredients

rivastigmine hydrogen tartrate

4.8 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 29.11.2017 at 11:28:58 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