VORICONAZOLE

Main information

  • Trade name:
  • VORICONAZOLE SANDOZ Voriconazole 200mg powder for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • VORICONAZOLE SANDOZ Voriconazole 200mg powder for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211977
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211977

VORICONAZOLE SANDOZ Voriconazole 200mg powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

7/07/2016

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. VORICONAZOLE SANDOZ Voriconazole 200mg powder for injection vial

Product Type

Single Medicine Product

Effective date

3/04/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

VORICONAZOLE SANDOZ is indicated for treatment of the following fungal infections:

-Invasive aspergillosis.

-Serious Candida infections (including C. krusei), including oesophageal and systemic Candida infections (hepatosplenic candidiasis, disseminated

candidiasis, candidaemia).

-Serious fungal infections caused by Scedosporium spp and Fusarium spp.

-Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.

-Prophylaxis in patients who are at high risk of developing invasive fungal infections. The indication is based on studies including patients undergoing

haematopoietic stem cell transplantation.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Not recorded

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

1 vial

(S4) Prescription Only Medicine

Components

1. VORICONAZOLE SANDOZ Voriconazole 200mg powder for injection vial

Dosage Form

Injection, powder for

Route of Administration

Intravenous Infusion

Visual Identification

VORICONAZOLE SANDOZ powder for injection is a white lyophilised

powder containing nominally 200 mg voriconazole

Active Ingredients

Voriconazole

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 27.11.2017 at 12:47:43 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

2-10-2018

Vfend (Pfizer Europe MA EEIG)

Vfend (Pfizer Europe MA EEIG)

Vfend (Active substance: voriconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6490 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000387/T/0130

Europe -DG Health and Food Safety

25-9-2018

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Hikma FarmacEutica (Portugal), S.A.)

Voriconazole Hikma (Active substance: voriconazole) - Centralised - Yearly update - Commission Decision (2018)6286 of Tue, 25 Sep 2018

Europe -DG Health and Food Safety