ABILIFY

Main information

  • Trade name:
  • ABILIFY MAINTENA aripiprazole (as monohydrate) 300 mg powder and solvent for prolonged release suspension for injection vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ABILIFY MAINTENA aripiprazole (as monohydrate) 300 mg powder and solvent for prolonged release suspension for injection vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211122
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211122

ABILIFY MAINTENA aripiprazole (as monohydrate) 300 mg powder and solvent for prolonged release

suspension for injection vial

ARTG entry for

Medicine Registered

Sponsor

Lundbeck Australia Pty Ltd

Postal Address

PO Box 1973,MACQUARIE CENTRE, NSW, 2113

Australia

ARTG Start Date

25/07/2014

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. ABILIFY MAINTENA aripiprazole (as monohydrate) 300 mg powder and solvent for prolonged release

suspension for injection vial

Product Type

Composite Pack

Effective date

13/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

For the acute and maintenance treatment of schizophrenia in adults.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store below 30

degrees Celsius

Child resistant closure

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

One 10 mL vial of powder with one 2 mL vial of diluent

(S4) Prescription Only Medicine

Components

1. Water for injections USP 2 mL vial

Dosage Form

Injection, diluent for

Route of Administration

Intramuscular

Visual Identification

2 mL clear glass vial containing a clear colourless liquid, stoppered with a

FluroTec Plus laminated gray bromobutyl rubber stopper and sealed with

an aluminium flip-off cap with plastic flip-off disc

2. Aripiprazole (as monohydrate) 300 mg powder for injection, vial

Dosage Form

Injection, powder for

Route of Administration

Intramuscular

Visual Identification

10 mL clear glass vial containing a white to off-white powder, stoppered

with a teflon laminated chlorobutyl rubber stopper and sealed with an

aluminium flip-off seal with yellow polypropylene flip-off top

Active Ingredients

aripiprazole

300 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 01:38:30 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

18-10-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Otsuka Pharmaceutical Netherlands B.V.)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6925 of Thu, 18 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002755/T/0026

Europe -DG Health and Food Safety

29-8-2018

ABILIFY MAINTENA (Otsuka Pharmaceutical Europe Ltd)

ABILIFY MAINTENA (Otsuka Pharmaceutical Europe Ltd)

ABILIFY MAINTENA (Active substance: Aripiprazole) - Centralised - Renewal - Commission Decision (2018)5780 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2755/R/25

Europe -DG Health and Food Safety

28-8-2018

Abilify (Otsuka Pharmaceutical Netherlands B.V.)

Abilify (Otsuka Pharmaceutical Netherlands B.V.)

Abilify (Active substance: aripiprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5681 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/471/T/131

Europe -DG Health and Food Safety