NEVIRA nevirapine 200 mg tablets blister pack

Main information

  • Trade name:
  • NEVIRA nevirapine 200 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • NEVIRA nevirapine 200 mg tablets blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 195527
  • Last update:
  • 21-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

195527

NEVIRA nevirapine 200 mg tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Sun Pharma ANZ Pty Ltd

Postal Address

Suite 2 02 Level 2 12 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

7/11/2012

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. NEVIRA nevirapine 200 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

2/02/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Nevirapine in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults and adolescents over the age of 16

years.,Resistant virus emerges rapidly when Nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent.

Therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. NEVIRA nevirapine 200 mg tablets blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White to off-white, oval-shaped, uncoated tablets with a break line on both

sides and debossed with 'RX921' on one side.

Active Ingredients

Nevirapine

200 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 28.11.2017 at 03:53:44 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