BLOOMS

Main information

  • Trade name:
  • BLOOMS THE CHEMIST DESVENLAFAXINE MR desvenlafaxine 100mg (as succinate monohydrate) modified release tablets blister
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BLOOMS THE CHEMIST DESVENLAFAXINE MR desvenlafaxine 100mg (as succinate monohydrate) modified release tablets blister
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215819
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215819

BLOOMS THE CHEMIST DESVENLAFAXINE MR desvenlafaxine 100mg (as succinate monohydrate)

modified release tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

17/10/2014

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. BLOOMS THE CHEMIST DESVENLAFAXINE MR desvenlafaxine 100mg (as succinate monohydrate)

modified release tablets blister

Product Type

Single Medicine Product

Effective date

17/10/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

BLOOM THE CHEMIST DESVENLAFAXINE MR modified release tablets are indicated for the treatment of major depressive disorder, including the

prevention of relapse.,It is not indicated for paediatric use.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. BLOOMS THE CHEMIST DESVENLAFAXINE MR desvenlafaxine 100mg (as succinate monohydrate) modified release tablets blister

Dosage Form

Tablet, modified release

Route of Administration

Oral

Visual Identification

Reddish orange coloured, rounded square shaped biconvex film-coated

tablets engraved with 'APO' on one side and 'DV' over '100' on the other

side.

Active Ingredients

Desvenlafaxine

100 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 08:08:13 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

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

There are no news related to this product.