MCGLOIN'S

Main information

  • Trade name:
  • MCGLOIN'S BENZEMUL benzyl benzoate 250mg/mL application bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MCGLOIN'S BENZEMUL benzyl benzoate 250mg/mL application bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 11491
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

120129

Schuessler Tissue Salts Menstrual Pain Comb N

ARTG entry for

Medicine Listed (Export Only)

Sponsor

Martin & Pleasance Pty Ltd

Postal Address

PO Box 2007,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

27/06/2005

Product category

Medicine

Status

Active

Approval area

Export only Medicines

Conditions

Except where the sponsor has been contracted by an overseas partry to manufacturer the goods and that party will be responsible for placing the goods

on the market in countries other than Australia, the sponsor must have and shall retain, while the goods remain listed, evidence necessary to

substantiate and support the accuracy of the indications in relation to the listed goods, and upon the request of the Head, Office of Prescription

Medicines Authorisation Branch, Therapeutic Goods Administration, shall produce such evidence to this officer.

The conditions applying to these goods when they are exported from Australia are given below:

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, other than condition No. 8 and condition No. 9.

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, other than condition No.11

The sponsor shall hold stability data to support the claimed shelf life of the listed medicine according to the labelled storage conditions except where: (i)

each overseas importer accepts responsibility for holding stability data for this product; (ii) the sponsor has a written agreement to this effect from each

overseas importer; and (iii) the sponsor retains copies of all such agreements while the medicine remains listed on the ARTG.

This product must not be supplied for sale in Australia, including supply via duty free outlets.

Products

1. Schuessler Tissue Salts Menstrual Pain Comb N

Product Type

Single Medicine Product

Effective date

27/06/2005

Warnings

(If medicine contains one sugar) contains [insert name of sugar] OR (If medicine contains two or more sugars) Contains sugars [or words to that effect].

Homoeopathic product without approved therapeutic indications (or words to that effect).

Contains lactose (or words to that effect).

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

Homoeopathic product/preparation or medicine (or words to that effect)

Standard Indications

Specific Indications

For the temporary relief of menstrual pain, stomach cramps, bloating and headaches.

Additional Product information

Pack Size/Poison information

Pack Size

Poison Schedule

Components

1. Medicine Component

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

Active Ingredients

calcium hydrogen phosphate dihydrate (Homeopathic)

4.85 mg

dibasic potassium phosphate trihydrate (Homeopathic)

4.85 mg

magnesium phosphate pentahydrate (Homeopathic)

4.85 mg

potassium chloride (Homeopathic)

4.85 mg

Public Summary

Page 1 of

Produced at 01.12.2017 at 09:46:22 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

© 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 01.12.2017 at 09:46:22 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

21-2-2019


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Orphan designation: N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4 methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide (entrectinib), Treatment of neuroblastoma, 11/11/2015, Withdrawn

Orphan designation: N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4 methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide (entrectinib), Treatment of neuroblastoma, 11/11/2015, Withdrawn

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EU/3/18/2105 (IQVIA RDS Ireland Limited)

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EU/3/18/2105 (Active substance: 6,8-bis(benzylthio)octanoic acid) - Orphan designation - Commission Decision (2018)9020 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/167/18

Europe -DG Health and Food Safety

7-12-2018


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Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Orphan designation: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione, Treatment of systemic sclerosis, 12/10/2017, Positive

Europe - EMA - European Medicines Agency

22-11-2018

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Emerald Health Pharmaceuticals EspaNa, S.L.)

EU/3/17/1933 (Active substance: (1'R,6'R)-3-(benzylamine)-6-hydroxy-3'-methyl-4-pentyl-6'-(prop-1-en-2-yl)-[1,1'-bi(cyclohexane)]-2',3,6-triene-2,5-dione) - Transfer of orphan designation - Commission Decision (2018)7813 of Thu, 22 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/0000001966

Europe -DG Health and Food Safety

5-7-2018

Withdrawn application:  Prohippur, sodium benzoate, Initial authorisation

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29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

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