CIPLA

Main information

  • Trade name:
  • CIPLA ESCITALOPRAM escitalopram (as oxalate) 20 mg film coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CIPLA ESCITALOPRAM escitalopram (as oxalate) 20 mg film coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214520
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214520

CIPLA ESCITALOPRAM escitalopram (as oxalate) 20 mg film coated tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Cipla Australia Pty Ltd

Postal Address

Level 1 / 132-136 Albert Road,SOUTH MELBOURNE, VIC, 3205

Australia

ARTG Start Date

7/11/2014

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. CIPLA ESCITALOPRAM escitalopram (as oxalate) 20 mg film coated tablet blister pack

Product Type

Single Medicine Product

Effective date

7/11/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of major depression. ,Treatment of social anxiety disorder (social phobia). ,Treatment of generalised anxiety disorder. ,Treatment of

obsessive-compulsive disorder.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. CIPLA ESCITALOPRAM escitalopram (as oxalate) 20 mg film coated tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

White round biconvex film coated tablets plain on both sides.

Active Ingredients

escitalopram oxalate

25.548 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 26.11.2017 at 09:30:38 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

3-1-2012

Danish Pharmacovigilance Update, 15 December 2011

Danish Pharmacovigilance Update, 15 December 2011

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Atomoxetine (Strattera®) and the risk of increased blood pressure and heart rate, increased suspicion of risk of congenital malformations with the antiepileptic topiramate (Topimax® and others), and new recommendations for the antidepressant escitalopram.

Danish Medicines Agency

7-10-2011

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

Changed reimbursement for medicines for depression and anxiety as of 5 March 2012

With effect from 5 March 2012, the reimbursement is changed for certain medicinal products for treatment of depression and anxiety (antidepressants and anxiolytics). Based on the Reimbursement Committee's recommendation, the Danish Medicines Agency has decided that in future the general rule is that treatment with inexpensive medicines (e.g. sertraline and citalopram) must be attempted before reimbursement can be granted for more expensive medicines (e.g. escitalopram, duloxetine, pregabalin and agomelat...

Danish Medicines Agency

There are no news related to this product.