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AMANTADINE MEDICIANZ (Medicianz Healthcare Pty Ltd)

Product name
AMANTADINE MEDICIANZ
Sponsor
Medicianz Healthcare Pty Ltd
Date registered
Evaluation commenced
Decision date
Approval time
121 (255 working days
Active ingredients
Amantadine hydrochloride
Registration type
New generic medicine
Indication

Parkinson's Disease

Idiopathic Parkinson's disease; post-encephalitic parkinsonism; symptomatic parkinsonism (e.g. following CNS injury from carbon monoxide poisoning); arteriosclerotic parkinsonism; drug-induced extrapyramidal reactions.

Amantamed, Amantadine Medsurge, Amantadine Medicianz can be given alone for initial therapy or combined with anticholinergic drugs or L-dopa (see section 4.2 Dose and method of administration).

Note Amantamed, Amantadine Medsurge, Amantadine Medicianz is not indicated for the treatment of tardive dyskinesia.

Type A Virus Influenza

Prophylaxis of respiratory tract illness caused by Influenza Type A.

Prophylaxis in non-immunised individuals (including children) for whom influenza may have serious consequences (e.g. persons with chronic respiratory disease or diabetes mellitus).

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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