MEDI

Main information

  • Trade name:
  • MEDI CHOICE PERIOD PAIN IBUPROFEN MINI CAPS ibuprofen 200 mg capsules HDPE bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • MEDI CHOICE PERIOD PAIN IBUPROFEN MINI CAPS ibuprofen 200 mg capsules HDPE bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 209608
  • Last update:
  • 10-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

209608

MEDI CHOICE PERIOD PAIN IBUPROFEN MINI CAPS ibuprofen 200 mg capsules HDPE bottle

ARTG entry for

Medicine Registered

Sponsor

Nova Pharmaceuticals Australasia Pty Ltd

Postal Address

Suite 305 / 10 Norbrik Drive,BELLA VISTA, NSW, 2153

Australia

ARTG Start Date

16/05/2013

Product category

Medicine

Status

Active

Approval area

Non-Prescription Medicines

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. MEDI CHOICE PERIOD PAIN IBUPROFEN MINI CAPS ibuprofen 200 mg capsules HDPE bottle

Product Type

Single Medicine Product

Effective date

16/05/2013

Warnings

No Warnings included on Record

Standard Indications

Specific Indications

For the effective temporary relief of pain and discomfort associated with headaches, migraine and tension headache, sinus pain, muscular aches and

pains, toothache and dental procedures, period pain, arthritis, rheumatic pain and the aches and pain associated with colds and flu.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 25

degrees Celsius

Child resistant closure

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

Not scheduled. Not considered by committee

Components

1.

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Size '1' hard gel, pink and white capsule containing white, free-flowing

granular powder, printed "IBU 200" on the pink end.

Active Ingredients

Ibuprofen

200 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 10:14:32 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

25-3-2019


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20-3-2019


Management Board meeting: 21 March 2019, European Medicines Agency, Amsterdam, the Netherlands, from 21/03/2019 to 21/03/2019

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20-3-2019


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Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

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FDA - U.S. Food and Drug Administration

14-3-2019

Danish Medicines Agency to help build better drug regulatory authorities in low- and middle-income countries

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22-3-2019

On March 18th, the @US_FDA identified a Class I Recall, the most serious  type of recall: Cook Medical Inc. Recalls Transseptal Needle Due to  Risk of Detached Plastic Fragments. Find out more about the recall:  https://go.usa.gov/xEtdg  #FDA #MedicalDevi

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FDA - U.S. Food and Drug Administration

22-3-2019


Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 19-21 March 2019

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Europe - EMA - European Medicines Agency

22-3-2019

ACSS public statement, 14-15 May 2018

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Public statement for the Generic Medicines Working Group face-to-face meeting in Switzerland, May 2018

Therapeutic Goods Administration - Australia

21-3-2019

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevicepic.twitter.com/Wh9Sshjn6n

The @US_FDA is committed to protecting and promoting the public’s health. On March 25-26, the agency will host the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting. #FDA #MedicalDevicepic.twitter.com/Wh9Sshjn6n

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FDA - U.S. Food and Drug Administration

20-3-2019

Listed and assessed listed medicines: Application and submission user guide

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Guidance updated

Therapeutic Goods Administration - Australia

20-3-2019

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20-3-2019

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Therapeutic Goods Administration - Australia

19-3-2019

Always keep medicines out of reach of children! https://twitter.com/HHSGov/status/1107674662534815744 …

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FDA - U.S. Food and Drug Administration

19-3-2019


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Europe - EMA - European Medicines Agency

19-3-2019


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Europe - EMA - European Medicines Agency

19-3-2019

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Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2101 (TMC Pharma (EU) Limited)

EU/3/18/2101 (TMC Pharma (EU) Limited)

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Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1703 (TMC Pharma (EU) Limited)

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EU/3/16/1703 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2154 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004730

Europe -DG Health and Food Safety

19-3-2019

EU/3/16/1688 (TMC Pharma (EU) Limited)

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EU/3/16/1688 (Active substance: Setmelanotide) - Transfer of orphan designation - Commission Decision (2019)2153 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004734

Europe -DG Health and Food Safety

19-3-2019

EU/3/18/2052 (Dicerna Ireland Limited)

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Europe -DG Health and Food Safety

19-3-2019

EU/3/10/823 (Amryt Pharmaceuticals Designated Activity Company)

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EU/3/10/823 (Active substance: Lomitapide) - Transfer of orphan designation - Commission Decision (2019)2152 of Tue, 19 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004233

Europe -DG Health and Food Safety

18-3-2019

Over 300 children in the United States are treated for poisoning each day. Keep your kids safe by keeping toxic products and medicines out of reach:  http://bit.ly/2Y7fVA2  #PPW2019 #MondayThoughtspic.twitter.com/wchq0dVW5r

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FDA - U.S. Food and Drug Administration

18-3-2019

EU/3/16/1633 (Diamond ROC EOOD)

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Europe -DG Health and Food Safety

18-3-2019

EU/3/15/1587 (Diamond ROC EOOD)

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18-3-2019

EU/3/15/1584 (Diamond ROC EOOD)

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18-3-2019

EU/3/14/1329 (Diamond ROC EOOD)

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18-3-2019

EU/3/14/1247 (Diamond ROC EOOD)

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18-3-2019

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Europe -DG Health and Food Safety

18-3-2019

EU/3/07/471 (BPL Bioproducts Laboratory GmbH)

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EU/3/07/471 (Active substance: Human coagulation factor X) - Transfer of orphan designation - Commission Decision (2019)2158 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004129

Europe -DG Health and Food Safety

18-3-2019

EU/3/16/1742 (Worphmed Srl)

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EU/3/16/1742 (Active substance: Acebutolol hydrochloride) - Transfer of orphan designation - Commission Decision (2019)2157 of Mon, 18 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004715

Europe -DG Health and Food Safety

18-3-2019


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Europe - EMA - European Medicines Agency

18-3-2019


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Europe - EMA - European Medicines Agency

15-3-2019

We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.  https://go.usa.gov/

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FDA - U.S. Food and Drug Administration

15-3-2019

#FDA CDRH is responsible for protecting and promoting the public health.  We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.  #MedicalDevice

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FDA - U.S. Food and Drug Administration

15-3-2019


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Europe - EMA - European Medicines Agency

15-3-2019

Intrarosa (Endoceutics S.A.)

Intrarosa (Endoceutics S.A.)

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Europe -DG Health and Food Safety

15-3-2019

NovoMix (Novo Nordisk A/S)

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Europe -DG Health and Food Safety

15-3-2019

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Europe -DG Health and Food Safety

15-3-2019

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Europe -DG Health and Food Safety

15-3-2019

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Clinical Network Services (NL) B.V.)

EU/3/19/2139 (Active substance: Autologous adult live cultured osteoblasts) - Transfer of orphan designation - Commission Decision (2019)2105 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004280

Europe -DG Health and Food Safety

15-3-2019

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Vectura Ireland Limited)

EU/3/06/349 (Active substance: Apomorphine hydrochloride (inhalation use)) - Transfer of orphan designation - Commission Decision (2019)2115 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004495

Europe -DG Health and Food Safety

15-3-2019

EU/3/15/1597 (Otsuka Pharmaceutical Netherlands B.V.)

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Europe -DG Health and Food Safety

15-3-2019

EU/3/11/936 (BPL Bioproducts Laboratory GmbH)

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Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1800 (Boyd Consultants Limited)

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Europe -DG Health and Food Safety

15-3-2019

EU/3/16/1629 (Boyd Consultants Limited)

EU/3/16/1629 (Boyd Consultants Limited)

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Europe -DG Health and Food Safety

15-3-2019

EU/3/14/1396 (Boyd Consultants Limited)

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Europe -DG Health and Food Safety

15-3-2019

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Boyd Consultants Limited)

EU/3/11/895 (Active substance: Hydroxy-propyl-beta-cyclodextrin) - Transfer of orphan designation - Commission Decision (2019)2108 of Fri, 15 Mar 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000005321

Europe -DG Health and Food Safety

15-3-2019


Miglitol: List of nationally authorised medicinal products - PSUSA/00002061/201807

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Europe - EMA - European Medicines Agency

14-3-2019


Nitrous oxide, nitrous oxide / oxygen: List of nationally authorised medicinal products - PSUSA/00010572/201806

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Europe - EMA - European Medicines Agency

14-3-2019


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Europe - EMA - European Medicines Agency

14-3-2019

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (ECO Animal Health Europe Limited)

Aivlosin (Active substance: Tylvalosin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2091 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/83/T/77

Europe -DG Health and Food Safety

14-3-2019

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Pegasus Laboratories Ireland Limited)

Reconcile (Active substance: Fluoxetine) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2089 of Thu, 14 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/V/C/133/T/31

Europe -DG Health and Food Safety

14-3-2019


Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201804

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Milnacipran: List of nationally authorised medicinal products - PSUSA/00002063/201804

Europe - EMA - European Medicines Agency

14-3-2019

Webinar: Permitted indications for listed medicines

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Webinar for small to medium businesses, start-ups, researchers and those new to regulation

Therapeutic Goods Administration - Australia

13-3-2019


Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805

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Loperamide, loperamide / simeticone: List of nationally authorised medicinal products - PSUSA/00010665/201805

Europe - EMA - European Medicines Agency

13-3-2019

Luminity (Lantheus EU Limited)

Luminity (Lantheus EU Limited)

Luminity (Active substance: perflutren) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2049 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/654/T/27

Europe -DG Health and Food Safety

13-3-2019

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (Active substance: dinutuximab beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2061 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3918/T/10

Europe -DG Health and Food Safety

13-3-2019

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Basilea Pharmaceutica Deutschland GmbH)

Cresemba (Active substance: isavuconazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2069 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2734/T/20

Europe -DG Health and Food Safety

13-3-2019

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Janssen Pharmaceutica N.V.)

Stayveer (Active substance: bosentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2065 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/2644/T/25

Europe -DG Health and Food Safety