RIZATRIPTAN

Main information

  • Trade name:
  • RIZATRIPTAN AS rizatriptan (as benzoate) 5 mg orally disintegrating tablets blisters
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RIZATRIPTAN AS rizatriptan (as benzoate) 5 mg orally disintegrating tablets blisters
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222202
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222202

RIZATRIPTAN AS rizatriptan (as benzoate) 5 mg orally disintegrating tablets blisters

ARTG entry for

Medicine Registered

Sponsor

Generic Partners Pty Ltd

Postal Address

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

Australia

ARTG Start Date

20/03/2015

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. RIZATRIPTAN AS rizatriptan (as benzoate) 5 mg orally disintegrating tablets blisters

Product Type

Single Medicine Product

Effective date

20/03/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

for acute treatment of migraine attacks with or without aura.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Other composite

material

24 Months

Store below 25

degrees Celsius

Child resistant closure

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. RIZATRIPTAN AS rizatriptan (as benzoate) 5 mg orally disintegrating tablets blisters

Dosage Form

Tablet, orally disintegrating

Route of Administration

Sublingual

Visual Identification

White to off-white, round, flat face beveled edge tablets, debossed with 'C6'

on one side and 'C' on the other side, having a characteristic flavour

Active Ingredients

rizatriptan benzoate

7.265 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 11:57:03 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

There are no safety alerts related to this product.

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

Withdrawn application: Prohippur, sodium benzoate, Initial authorisation

Europe - EMA - European Medicines Agency