APO-TRAVOPROST/TIMOLOL (Apotex Pty Ltd)
Product name
APO-TRAVOPROST/TIMOLOL
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
171 working days (255)
Active ingredients
travoprost/timolol
Registration type
New generic medicine
Indication
APO-TRAVOPROST/TIMOLOL (eye drops) are indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension for whom single agent therapy provides insufficient intraocular pressure reduction.
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine