ESOMEPRAZOLE

Main information

  • Trade name:
  • ESOMEPRAZOLE GH esomeprazole (as magnesium) 40 mg enteric-coated tablet bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ESOMEPRAZOLE GH esomeprazole (as magnesium) 40 mg enteric-coated tablet bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 207589
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

207589

ESOMEPRAZOLE GH esomeprazole (as magnesium) 40 mg enteric-coated tablet bottle

ARTG entry for

Medicine Registered

Sponsor

Lupin Australia Pty Limited

Postal Address

Generic Health Pty Ltd,Level 1 1102 Toorak Road,CAMBERWELL, VIC, 3124

Australia

ARTG Start Date

27/05/2014

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 GH esomeprazole (as magnesium) 40 mg enteric-coated tablet bottle

Product Type

Single Medicine Product

Effective date

7/08/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Esomeprazole enteric-coated tablet indicated for:,1] Gastro-Oesophageal Reflux Disease (GORD),- Treatment of erosive reflux oesophagitis,- Long-term

management of patients with healed oesophagitis to prevent relapse,- Symptomatic treatment of gastro-oesophageal reflux disease (GORD),2] 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,- 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.,3] Prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole solution

administered by intravenous infusion.,4] Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion,In

combination with appropriate antibiotics for:,- Healing of duodenal ulcer associated with Helicobacter pylori,- Eradication of Helicobacter pylori in patients

with active or healed peptic ulcer

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 25

degrees Celsius

Not recorded

Keep Container

Tightly Closed/Airtight

Pack Size/Poison information

Pack Size

Poison Schedule

75 CC HDPE with 38 mm neck (with induction sealing liner) containing

molecular sieve desiccant canister) of 30's

(S4) Prescription Only Medicine

HDPE bottle pack (120CC HDPE bottle with 38 mm neck (with induction

sealing liner) containing molecular sieve desiccant canister.) of 56's

(S4) Prescription Only Medicine

Components

1. ESOMEPRAZOLE GH esomeprazole (as magnesium) 40 mg enteric-coated tablet bottle

Dosage Form

Tablet, enteric coated

Route of Administration

Oral

Visual Identification

Pink coloured, oblong, biconvex, coated tablets debossed with '40' on one

side and 'CE' on the other.

Active Ingredients

Esomeprazole magnesium

44.528 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 28.11.2017 at 12:19:25 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

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

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