Taliglucerase alfa

FDA Drug Profile — ELELYSO

Drug Details

Generic Name
Taliglucerase alfa
Brand Names
ELELYSO
Application Number
BLA022458
Sponsor
Pharmacia and Upjohn Company LLC
NDC Codes
4
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, LIQUID, 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 ).