DORZOLAMIDE TIMOLOL

Main information

  • Trade name:
  • DORZOLAMIDE/TIMOLOL SANDOZ 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drops solution bott
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DORZOLAMIDE/TIMOLOL SANDOZ 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drops solution bott
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211972
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211972

DORZOLAMIDE/TIMOLOL SANDOZ 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as

maleate) 5 mg/mL eye drops solution bottle

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

5/06/2014

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. DORZOLAMIDE/TIMOLOL SANDOZ 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate)

5 mg/mL eye drops solution bottle

Product Type

Single Medicine Product

Effective date

15/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

LDPE

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

5 mL

(S4) Prescription Only Medicine

Components

1. DORZOLAMIDE/TIMOLOL SANDOZ 20/5 dorzolamide (as hydrochloride) 20 mg/mL and timolol (as maleate) 5 mg/mL eye drops solution

bottle

Dosage Form

Eye Drops, solution

Route of Administration

Ophthalmic

Visual Identification

Colourless to slightly yellowish, viscious solution.

Active Ingredients

Dorzolamide hydrochloride

22.26 mg/mL

Timolol maleate

6.83 mg/mL

© 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 20.10.2017 at 03:56:44 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

5-6-2018

DuoTrav (Novartis Europharm Limited)

DuoTrav (Novartis Europharm Limited)

DuoTrav (Active substance: Travoprost / Timolol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3622 of Tue, 05 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/665/T/53

Europe -DG Health and Food Safety