CYPROTERONE ASCENT 100 cyproterone acetate 100mg tablet bottle

Main information

  • Trade name:
  • CYPROTERONE ASCENT 100 cyproterone acetate 100mg tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CYPROTERONE ASCENT 100 cyproterone acetate 100mg tablet bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 184225
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

184225

CYPROTERONE ASCENT 100 cyproterone acetate 100mg tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

23/05/2012

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. CYPROTERONE ASCENT 100 cyproterone acetate 100mg tablet bottle

Product Type

Single Medicine Product

Effective date

12/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Inoperable prostatic carcinoma. To suppress flare with initial luteinising hormone releasing hormone (LHRH) analogue therapy; in long-term palliative

treatment where LHRH analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred; in the treatment of hot

flushes in patients treated with LHRH analogues or who have had orchidectomy.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

3 Years

Store below 30

degrees Celsius

Not recorded

Protect from Light

Protect from Moisture

Pack Size/Poison information

Pack Size

Poison Schedule

50 tablets

(S4) Prescription Only Medicine

Components

1. CYPROTERONE ASCENT 100 cyproterone acetate 100mg tablet bottle

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off white, capsule shaped tablet with '100' engraved on one face,

and a break line on the other face.

Active Ingredients

cyproterone acetate

100 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 29.11.2017 at 05:03:29 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