GenRx

Main information

  • Trade name:
  • GenRx Cabergoline cabergoline 500 micrograms tablets bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GenRx Cabergoline cabergoline 500 micrograms tablets bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218128
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218128

GenRx Cabergoline cabergoline 500 micrograms tablets bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

20/11/2015

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. GenRx Cabergoline cabergoline 500 micrograms tablets bottle

Product Type

Single Medicine Product

Effective date

20/11/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

· Inhibition of physiological lactation ,Cabergoline is indicated for the prevention of the onset of physiological lactation in the puerperium for clearly

defined medical reasons. ,· Treatment of hyperprolactinaemic disorders ,Cabergoline is indicated for the treatment of pathological hyperprolactinaemia.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type III

Coloured

21 Months

Store below 25

degrees Celsius

Child resistant closure

Protect from Heat

Protect from Moisture

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

2 tablets

(S4) Prescription Only Medicine

8 tablets

(S4) Prescription Only Medicine

Components

1. GenRx Cabergoline cabergoline 500 micrograms tablets bottle

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White coloured, capsule shaped, flat, scored tablets with debossed "APO"

on one side and "CA" bisect "0.5" on the other side.

Active Ingredients

Cabergoline

500 microgram

© 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 05:25:14 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

20-7-2016

Marketing authorisation for medicine for cows suspended in the EU/EEA

Marketing authorisation for medicine for cows suspended in the EU/EEA

On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.

Danish Medicines Agency

There are no news related to this product.