Libra

Main information

  • Trade name:
  • Libra Applicator Tampon Super - Sanitary wear, tampon, menstrual
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Libra Applicator Tampon Super - Sanitary wear, tampon, menstrual
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218714
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218714

SCA Hygiene Australasia Pty Ltd - Libra Applicator Tampon Super - Sanitary wear, tampon, menstrual

ARTG entry for

Other Therapeutic Good - Listed other

Sponsor

Asaleo Care Australia Pty Ltd

Postal Address

PO Box 117,BOX HILL, VIC, 3128

Australia

ARTG Start Date

20/12/2013

Product category

Other Therapeutic Good

Status

Active

Approval area

Medical Devices

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. Libra Applicator Tampon Super - Sanitary wear, tampon, menstrual

Product Type

Single Device Product

Effective date

20/12/2013

GMDN

35694 Sanitary wear, tampon, menstrual

Intended purpose

To be inserted into the vagina to absorb menstrual discharge

Specific Conditions

No Specific Conditions included on Record

© 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 10.11.2017 at 09:35:08 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

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

3-5-2018

Hemlibra (Roche Registration GmbH)

Hemlibra (Roche Registration GmbH)

Hemlibra (Active substance: emicizumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)2774 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4406/T/1

Europe -DG Health and Food Safety