MICRONELLE

Main information

  • Trade name:
  • MICRONELLE 20 ED levonorgestrel 100 microgram and ethinylestradiol 20 microgram film-coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MICRONELLE 20 ED levonorgestrel 100 microgram and ethinylestradiol 20 microgram film-coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211154
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211154

MICRONELLE 20 ED levonorgestrel 100 microgram and ethinylestradiol 20 microgram film-coated tablet

blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

31/01/2014

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. MICRONELLE 20 ED levonorgestrel 100 microgram and ethinylestradiol 20 microgram film-coated tablet

blister pack

Product Type

Composite Pack

Effective date

14/11/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Oral contraception.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Not recorded

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

3 x 28

(S4) Prescription Only Medicine

4 x 28 tablets

(S4) Prescription Only Medicine

1 x 28

(S4) Prescription Only Medicine

Components

1. Active

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Plain, round, pink tablet.

Active Ingredients

ethinylestradiol

20 microgram

Levonorgestrel

100 microgram

2. Placebo

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

Plain, round, white tablet.

© 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 27.11.2017 at 01:37:37 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

There are no safety alerts related to this product.