PEXOLE

Main information

  • Trade name:
  • PEXOLE pramipexole dihydrochloride 1 mg tablets blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PEXOLE pramipexole dihydrochloride 1 mg tablets blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214445
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214445

PEXOLE pramipexole dihydrochloride 1 mg tablets blister pack

ARTG entry for

Medicine Registered

Sponsor

Generic Partners Pty Ltd

Postal Address

Level 1 / 313 Burwood Road,Hawthorn, VIC, 3122

Australia

ARTG Start Date

23/09/2014

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. PEXOLE pramipexole dihydrochloride 1 mg tablets blister pack

Product Type

Single Medicine Product

Effective date

23/09/2014

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Pramipexole tablets are indicated for:,-the treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in

combination with levodopa.,-the symptomatic treatment of primary Restless Legs Syndrome.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

3 Years

Store below 25

degrees Celsius

Child resistant closure

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

10, 30, 100

(S4) Prescription Only Medicine

Components

1. PEXOLE Pramipexole hydrochloride 1 mg tablets blister pack

Dosage Form

Tablet, uncoated

Route of Administration

Oral

Visual Identification

White, circular, flat, beveled edged uncoated tablets debossed with 'CL' and

'5' debossed on one side with breakline in between and a breakline on the

other side.

Active Ingredients

pramipexole dihydrochloride monohydrate

1 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 09:48:45 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

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EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Celgene Europe B.V.)

EU/3/10/810 (Active substance: N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate) - Transfer of orphan designation - Commission Decision (2018)3808 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/084/10/T/03

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EU/3/10/794 (Celgene Europe B.V.)

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EU/3/11/887 (Gilead Sciences Ireland UC)

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EU/3/11/887 (Active substance: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt) - Transfer of orphan designation - Commission Decision (2018)3801 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/020/11/T/03

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EU/3/11/886 (Gilead Sciences Ireland UC)

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