MEN'S

Main information

  • Trade name:
  • MEN'S REGAINE EXTRA STRENGTH minoxidil 5% topical application bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEN'S REGAINE EXTRA STRENGTH minoxidil 5% topical application bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 79914
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

79914

MEN'S REGAINE EXTRA STRENGTH minoxidil 5% topical application bottle

ARTG entry for

Medicine Registered

Sponsor

Johnson & Johnson Pacific Pty Ltd

Postal Address

Locked Bag 5,

BROADWAY, NSW, 2007

Australia

ARTG Start Date

30/08/2001

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. MEN'S REGAINE EXTRA STRENGTH minoxidil 5% topical application bottle

Product Type

Single Medicine Product

Effective date

18/03/2016

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the treatment of androgenic alopecia (common baldness) in healthy adult males and females.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Not recorded

3 Years

Store below 30

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

3 x 60mL

(S2) Pharmacy Medicine

4 x 60mL

(S2) Pharmacy Medicine

1 x 60mL

(S2) Pharmacy Medicine

Components

1.

Dosage Form

Application

Route of Administration

Topical

Visual Identification

Clear, colourless to light yellow liquid.

Active Ingredients

Minoxidil

50 mg/mL

© 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 01.12.2017 at 08:33:21 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