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AMBRISENTAN SANDOZ (Sandoz Pty Ltd)
Product name
AMBRISENTAN SANDOZ
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
135 (255 working days)
Active ingredients
ambrisentan
Registration type
New generic medicine
Indication
AMBRISENTAN SANDOZ (film-coated tablets) is indicated for the treatment of:
- idiopathic pulmonary arterial hypertension (PAH),
- pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD),
in patients with WHO functional class II, III or IV symptoms.