Summary for ARTG Entry:
TRANDOLAPRIL AN trandolapril 1 mg capsule blister pack
ARTG entry for
Amneal Pharma Australia Pty Ltd
12 River Street,SOUTH YARRA, VIC, 3141
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. TRANDOLAPRIL AN trandolapril 1 mg capsule blister pack
Single Medicine Product
See Product Information and Consumer Medicine Information for this product
Trandolapril is indicated for the treatment of hypertension. Data to support the usage of trandolapril in renovascular hypertension are, at present, not
available. Trandolapril is also indicated for patients with left ventricular dysfunction post myocardial infarction [ejection fraction less than or equal to 35%
or WMI (Wall Motion Index) less than or equal to 1.2].
Additional Product information
Store below 25
Store in a Dry Place
Pack Size/Poison information
(S4) Prescription Only Medicine
1. TRANDOLAPRIL AN trandolapril 1 mg capsule
Route of Administration
"Size 4" Orange coloured cap imprinted with 'TR' in black ink and light
orange coloured body imprinted with '1' in black ink
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Produced at 29.11.2017 at 02:12:15 AEDT
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