BEHISTATINE

Main information

  • Trade name:
  • BEHISTATINE betahistine dihydrochloride 16 mg tablets blister packs
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BEHISTATINE betahistine dihydrochloride 16 mg tablets blister packs
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212084
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212084

BEHISTATINE betahistine dihydrochloride 16 mg tablets blister packs

ARTG entry for

Medicine Registered

Sponsor

Generic Partners Pty Ltd

Postal Address

Level 1 / 313 Burwood Road,Hawthorn, VIC, 3122

Australia

ARTG Start Date

14/08/2014

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. BEHISTATINE betahistine dihydrochloride 16 mg tablets blister packs

Product Type

Single Medicine Product

Effective date

5/12/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Meniere's Syndrome as defined by the following core symptoms: vertigo (with nausea/vomiting), hearing loss (hardness of hearing) and tinnitus

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PA/Al/PVC/Al -

polyamide-aluminium

foil-polyvinylchloride/al

uminium foil

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Store in Original

Container

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

25 tablets

(S4) Prescription Only Medicine

30 tablets

(S4) Prescription Only Medicine

10 tablets

(S4) Prescription Only Medicine

100 tablets

(S4) Prescription Only Medicine

60 tablets

(S4) Prescription Only Medicine

Components

1. BEHISTATINE betahistine dihydrochloride 16 mg tablets blister packs

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Uncoated, round, biconvex, white to light creamy tablets, with a groove on

one surface.

Active Ingredients

betahistine dihydrochloride

16 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 27.11.2017 at 12:39:00 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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