PRONAT

Main information

  • Trade name:
  • PRONAT GROUP FISIOCREM MASSAGE BLEND
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PRONAT GROUP FISIOCREM MASSAGE BLEND
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207962
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207962

PRONAT GROUP FISIOCREM MASSAGE BLEND

ARTG entry for

Medicine Listed

Sponsor

Pronat Group Australia Pty Ltd

Postal Address

6/36 Newheath Drive,ARUNDEL, QLD, 4214

Australia

ARTG Start Date

9/04/2013

Product category

Medicine

Status

Active

Approval area

Listed Medicines

Conditions

The sponsor shall keep records relating to this listed medicine as are necessary to: (a) Expedite recall if necessary of any batch of the listed medicine,

(b) Identify the manufacturer(s) of each batch of the listed medicine. Where any part of or step in manufacture in Australia of the listed medicine is

sub-contracted to a third party who is not the sponsor, copies of relevant Good Manufacturing Practice agreements relation to such manufacture shall be

kept.

The sponsor shall retain records of the distribution of the listed medicine for a period of five years and shall provide the records or copies of the records

to the Complementary Medicines Branch, Therapeutic Goods Administration, upon request.

The sponsor of the listed medicine must not, by any means, intentionally or recklessly advertise the medicine for an indication other than those accepted

in relation to the inclusion of the medicine in the Register.

All reports of adverse reactions or similar experiences associated with the use or administration of the listed medicine shall be notified to the Head, Office

of Product Review, Therapeutic Goods Administration, as soon as practicable after the sponsor of the goods becomes aware of those reports. Sponsors

of listed medicines must retain records of such reports for a period of not less than 18 months from the day the Head, Office of Product Review is notified

of the report or reports.

The sponsor shall not supply the listed medicine after the expiry date of the goods.

Where a listed medicine is distributed overseas as well as in Australia, product recall or any other regulatory action taken in relation to the medicine

outside Australia which has or may have relevance to the quality, safety or efficacy of the goods distributed in Australia, must be notified to the National

Manager Therapeutic Goods Administration, immediately the action or information is known to the sponsor.

Products

1. PRONAT GROUP FISIOCREM MASSAGE BLEND

Product Type

Single Medicine Product

Effective date

9/04/2013

Warnings

If symptoms persist consult your healthcare practitioner (or words to that effect).

Standard Indications

May assist in the management of lower back pain.[Warning S required]

May assist in the management of sprains. [Warning S required]

For the symptomatic relief of sprains. [Warning S required]

For the symptomatic relief of low back pain. [Warning S required]

Relief of the pain of sciatica. [Warning S required]

May assist in the management of sciatica. [Warning S required]

Temporary relief of lower back pain. [Warning S required]

Temporary relief of the painful symptoms of sciatica and whiplash. [Warning S required]

For the symptomatic relief of soft tissue trauma. [Waring S required]

Relief of muscular cramps and spasms. [Warning S required]

May assist in the management of soft tissue trauma. [Warning S required]

Relief of muscular aches and pains. [Warning S required]

Relieves aching legs associated with enlarged or varicose veins. [Warning S required]

Specific Indications

Natural solution for the temporary relief of muscle and joint pain

Fisiocrem offers fast release of active ingredients to provide relief for common muscle, joint, and back pains resulting from everyday life and sports

injuries. Natural solution for muscle and joint pain.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

Public Summary

Page 1 of

Produced at 20.10.2017 at 02:31:09 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

1. Formulation 1

Dosage Form

Route of Administration

Topical

Visual Identification

Active Ingredients

Arnica montana

105 mg/g

Equivalent: Arnica montana (Dry)

10.5 mg/g

Calendula officinalis

25 mg/g

Equivalent: Calendula officinalis (Dry)

2.5 mg/g

Hypericum perforatum

25 mg/g

Equivalent: Hypericum perforatum (Dry)

2.5 mg/g

Melaleuca Oil

10 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 2 of

Produced at 20.10.2017 at 02:31:09 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.