Summary for ARTG Entry:
PEXOLE pramipexole dihydrochloride 0.5 mg tablets blister pack
ARTG entry for
Generic Partners Pty Ltd
Level 1 / 313 Burwood Road,Hawthorn, VIC, 3122
ARTG Start Date
Drug Safety Evaluation Branch
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.
1. PEXOLE pramipexole dihydrochloride 0.5 mg tablets blister pack
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
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
Store below 25
Child resistant closure
Protect from Light
Pack Size/Poison information
10, 30, 100
(S4) Prescription Only Medicine
1. PEXOLE Pramipexole hydrochloride 0.5 mg tablets blister pack
Route of Administration
White, oval, uncoated tablets debossed with 'CL' and '4' debossed on one
side with breakline in between and a breakline on the other side.
pramipexole dihydrochloride monohydrate
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Produced at 26.11.2017 at 09:47:16 AEDT
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