Taliglucerase alfa

FDA Drug Profile — ELELYSO

Taliglucerase alfa is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including ELELYSO. Available dosage forms: liquid, injection, powder, lyophilized, for solution, injection, powder, for solution.

Drug Details

Generic Name
Taliglucerase alfa
Brand Names
ELELYSO
Application Number
BLA022458
Sponsor
Protalix Ltd
NDC Codes
4
Dosage Forms
LIQUID, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients
TALIGLUCERASE ALFA

Indications and Usage

1 INDICATIONS AND USAGE ELELYSO is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of Type 1 Gaucher disease. ELELYSO is a hydrolytic lysosomal glucocerebroside-specific enzyme indicated for the treatment of patients 4 years and older with a confirmed diagnosis of Type 1 Gaucher disease ( 1 ).