ESOMEPRAZOLE

Main information

  • Trade name:
  • ESOMEPRAZOLE ACTAVIS esomeprazole magnesium dihydrate 20 mg enteric coated tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ESOMEPRAZOLE ACTAVIS esomeprazole magnesium dihydrate 20 mg enteric coated tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210854
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210854

ESOMEPRAZOLE ACTAVIS esomeprazole (as magnesium dihydrate) 20 mg enteric coated tablet blister

pack

ARTG entry for

Medicine Registered

Sponsor

Medis Pharma Pty Ltd

Postal Address

PO Box 6127,North Sydney, NSW, 2059

Australia

ARTG Start Date

30/07/2014

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. ESOMEPRAZOLE ACTAVIS esomeprazole magnesium dihydrate 20 mg enteric coated tablet blister pack

Product Type

Single Medicine Product

Effective date

21/07/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

It is indicated for:,Gastro-Oesophageal Reflux Disease (GORD): treatment of erosive reflux oesophagitis, long-term management of patients with healed

oesophagitis to prevent relapse and symptomatic treatment of gastro-oesophageal reflux disease (GORD).,Patients requiring NSAID therapy: short-term

treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy,

healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy and prevention of

gastric and duodenal ulcers associated with non-steroidal anti inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at

risk.,Prevention of rebleeding of gastric or duodenal ulcers following treatment with IV Esomeprazole solution by intravenous infusion (intravenous

dosage form can be available from other brands).,Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic

hypersecretion, in combination with appropriate antibiotics for:

healing of duodenal ulcer associated with Helicobacter pylori and eradication of Helicobacter pylori in patients with active or healed peptic ulcer.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Store in Original

Container

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1. ESOMEPRAZOLE ACTAVIS esomeprazole magnesium dihydrate 20mg enteric coated tablet blister pack

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

elliptically shaped, biconvex, light pink enteric coated tablets

Active Ingredients

esomeprazole magnesium dihydrate

21.75 mg

Public Summary

Page 1 of

Produced at 27.11.2017 at 01:51:28 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

© 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 2 of

Produced at 27.11.2017 at 01:51:28 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

8-9-2009

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

Decision on future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds)

On 3 september 2009, the Danish Medicines Agency decided on the future reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium compounds).

Danish Medicines Agency

4-5-2009

Consultation on the reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

Consultation on the reimbursement status of medicinal products in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicinal products authorised for marketing in Denmark in ATC group A06 (laxatives) and A02AA04 (magnesium hydroxide)

Danish Medicines Agency

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

7-8-2018

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5419 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5420 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

27-6-2018

Nexium Control (Pfizer Consumer Healthcare Limited)

Nexium Control (Pfizer Consumer Healthcare Limited)

Nexium Control (Active substance: esomeprazole) - Centralised - Renewal - Commission Decision (2018) 4111 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2618/R/21

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

5-2-2018

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Dany Bienenwohl GmbH)

Oxybee (Active substance: oxalic acid dihydrate) - New authorisation - Commission Decision (2018)684 of Mon, 05 Feb 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4296

Europe -DG Health and Food Safety