PROPESS

Main information

  • Trade name:
  • PROPESS dinoprostone 10 mg pessary sachet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PROPESS dinoprostone 10 mg pessary sachet
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218259
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218259

PROPESS dinoprostone 10 mg pessary sachet

ARTG entry for

Medicine Registered

Sponsor

Ferring Pharmaceuticals Pty Ltd

Postal Address

PO Box 315,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

26/09/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

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. PROPESS dinoprostone 10 mg pessary sachet

Product Type

Single Medicine Product

Effective date

26/09/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Cervical ripening in patients, at or near term, who have favourable induction features and in whom there is a medical or obstetrical indication for induction

of labour.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Sachet

Al laminated with

PE/paper

36 Months

Store below minus 18

degrees Celsius (deep

freeze)

Not recorded

Store in a deep freeze

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. PROPESS dinoprostone 10 mg pessary sachet

Dosage Form

Pessary

Route of Administration

Vaginal

Visual Identification

Thin, flat, polymeric pessary, rectangular in shape with rounded corners. It

is contained within an off-white knitted polyester retrieval system.

Active Ingredients

Dinoprostone

10 mg

© 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 26.11.2017 at 05:15:32 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