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