Public Summary

Summary for ARTG Entry: 9984 PROSTIN E2 VAGINAL GEL 2mg (Dinoprostone)

ARTG entry for Medicine Registered

Sponsor Pfizer Australia Pty Ltd

Postal Address Level 17 151 Clarence Street, Sydney, NSW, 2000
Australia
ARTG Start Date 27/08/1991
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 . PROSTIN E2 VAGINAL GEL 2mg

Public Summary
Product Type Single Medicine Product Effective Date 13/07/2020

Permitted Indications
No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

For induction of labour in term or near-term pregnant women who have favourable induction features. INDICATIONS AS AT 27 AUGUST 2003: Induction of
labour in term or near-term pregnant women who have favourable induction features; and who have singleton pregnancy with a vertex presentation.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type Material Life Time Temperature Closure Conditions

Syringe LDPE 2 Years Store at 2 to 8 Not recorded Do not Freeze
degrees Celsius

Pack Size/Poison information

Pack Size Poison Schedule

3g (wt) or 2.5mL (vol) (S4) Prescription Only Medicine

Components
1 . Medicine Component

Dosage Form Gel

Route of Administration Vaginal
Visual Identification Homogenous, colourless, semi-translucent viscous gel.

Active Ingredients

dinoprostone .6667 mg/g

Other Ingredients (Excipients)

colloidal anhydrous silica

Page 1 of 2 Produced at 10.08.2021 at 12:18:15 AEST

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
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Public Summary

Page 2 of 2 Produced at 10.08.2021 at 12:18:15 AEST

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