AMCAL

Main information

  • Trade name:
  • AMCAL FEM-V PLUS fluconazole 150mg capsule and clotrimazole 10mg/g cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • AMCAL FEM-V PLUS fluconazole 150mg capsule and clotrimazole 10mg/g cream
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211457
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211457

AMCAL FEM-V PLUS fluconazole 150mg capsule and clotrimazole 10mg/g cream

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

26/06/2013

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-V PLUS fluconazole 150mg capsule and clotrimazole 10mg/g cream

Product Type

Composite Pack

Effective date

3/02/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

Treatment of vaginal and vulvovaginal candidiasis.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Multiple containers

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

10mg/g (1%) clotrimazole cream tube (10g)/150mg fluconazole capsule (1)

(S3) Pharmacist Only Medicine

Components

1. Amcal Fem-V Plus clotrimazole 10mg/g cream

Dosage Form

Cream

Route of Administration

Vaginal

Topical

Visual Identification

White, smooth semi-solid cream

Active Ingredients

Clotrimazole

10 mg/g

2. Amcal Fem V Plus Fluconazole 150mg capsule

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Hard gelatin capsules of size '1' with sky blue opaque body and cap

Active Ingredients

Fluconazole

150 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 23.11.2017 at 08:37:39 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

2-8-2018

"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

"Jian Pai Natural Skin Care Cream" contains antifungal drugs not listed on the label, which may pose serious health risks

Health Canada testing of “Jian Pai Natural Skin Care Cream,” also called ‘’Yikangshuang,” found that it contains two antifungal drugs (fluconazole and miconazole) that are not listed on the product label, and may pose serious health risks.

Health Canada

24-5-2018

Consultation:  miconazole and fluconazole: proposed advisory statements for medicines

Consultation: miconazole and fluconazole: proposed advisory statements for medicines

The TGA is seeking comments on the proposed RASML statements for OTC medicines containing miconazole or fluconazole. Closing date: 21 June 2018

Therapeutic Goods Administration - Australia