Follicle

Main information

  • Trade name:
  • Follicle stimulating hormone pen
  • Class:
  • Class Im
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Follicle stimulating hormone pen
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217497
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217497

Merck Sharp & Dohme Australia Pty Ltd - Follicle stimulating hormone pen

ARTG entry for

Medical Device Included Class Im

Sponsor

Merck Sharp & Dohme (Australia) Pty Ltd

Postal Address

North Ryde Post Business Centre,Locked Bag 2234,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

19/11/2013

Product category

Medical Device Class Im

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

BD Medical Pharmaceutical Systems

1 Becton Drive

Franklin Lakes, New Jersey, 07417

United States Of America

Products

1. Follicle stimulating hormone pen

Product Type

Single Device Product

Effective date

19/11/2013

GMDN

60722 Follicle stimulating hormone pen

Intended purpose

For self-injection by an adult patient of a desired dose of follicle stimulating hormone. Injection is acheived

by loading follicle stimulating hormone cartridge and attaching disposable pen needle. This is a reusable

device.

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 02:09:41 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