LUCENTIS

Main information

  • Trade name:
  • LUCENTIS ranibizumab (rbe) 1.65 mg/0.165 mL solution for injection prefilled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LUCENTIS ranibizumab (rbe) 1.65 mg/0.165 mL solution for injection prefilled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 212387
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

212387

LUCENTIS ranibizumab (rbe)1.65 mg/0.165 mL solution for injection prefilled syringe

ARTG entry for

Medicine Registered

Sponsor

Novartis Pharmaceuticals Australia Pty Ltd

Postal Address

PO Box 101,NORTH RYDE, NSW, 1670

Australia

ARTG Start Date

5/11/2013

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. LUCENTIS ranibizumab (rbe) 1.65 mg/0.165 mL solution for injection prefilled syringe

Product Type

Single Medicine Product

Effective date

22/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Lucentis (ranibizumab) is indicated in adults for:,- the treatment of neovascular (wet) age-related macular degeneration (AMD).,- the treatment of visual

impairment due to choroidal neovascularisation.,- the treatment of visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic

myopia (PM).,- the treatment of visual impairment due to diabetic macular oedema (DME).,- the treatment of visual impairment due to macular oedema

secondary to retinal vein occlusion (RVO).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Not recorded

Refrigerate

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x prefilled syringe

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Injection, solution

Route of Administration

Intravitreal-Within The Vitreous Cavity Of The Eye

Visual Identification

Clear, colourless to pale yellow solution

Active Ingredients

Ranibizumab

1.65 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 11.11.2017 at 04:52:26 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