AMCAL

Main information

  • Trade name:
  • AMCAL FEM V3 DAY CREAM clotrimazole 20mg/g tube
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMCAL FEM V3 DAY CREAM clotrimazole 20mg/g tube
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209486
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209486

AMCAL FEM V3 DAY CREAM clotrimazole 20mg/g tube

ARTG entry for

Medicine Registered

Sponsor

Cipla Australia Pty Ltd

Postal Address

Level 1 / 132-136 Albert Road,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

14/05/2013

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

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. AMCAL FEM V3 DAY CREAM clotrimazole 20mg/g tube

Product Type

Single Medicine Product

Effective date

2/02/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the effective treatment of vaginal candidiasis and the relief of symptoms of vaginal candidiasis such as itching, burning and vaginal discharge.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Tube

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

1 carton of 1 tube 20g cream

(S3) Pharmacist Only Medicine

Components

1.

Dosage Form

Cream

Route of Administration

Vaginal

Visual Identification

White smooth semi-solid cream

Active Ingredients

Clotrimazole

20 mg/g

© 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 23.11.2017 at 08:38:22 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