Investor Presentaiton
Definitions
DRUG CATEGORY
New Drugs
Branded Generics
Non-Branded
Generics
(Similar Drugs)
DEFINITIONS
Innovative products for which safety, efficacy and quality have been
proven via multiple non-clinical and clinical studies before registration with
Anvisa.
Products that contain the same active ingredient(s), has the same
concentration, dosage form, administration route, dosage administration
and therapeutic recommendation, as the reference drug registered with
Anvisa. It may differ only in the product's size and form, expiration date,
packaging, labelling, excipients, and it must always be identified by trade
name or brand name.
Products that contain the same active ingredient, formulation,
pharmaceutical form, mode of administration, dosage and indication than
the reference drug that drugs already registered with Anvisa. They are
intended to be interchangeable with the reference product.View entire presentation