ACTIVE SUBSTANCE / INN

ALGLUCOSIDASE ALFA

Brand name(s): Myozyme, LUMIZYME, MYOZYME

FDA LISTED

EMA LISTED

PRESCRIPTION

AUTHORISED

BLA125141

BLA125291

ACTIVE SUBSTANCE

Alglucosidase Alfa

REGULATORS

FDA · EMA

SPONSORS / MAH

Sanofi B.V., GENZYME

TOTAL APPLICATIONS

3

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
LUMIZYME	BLA125291	GENZYME	Prescription
MYOZYME	BLA125141	GENZYME	Prescription

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Myozyme	Sanofi B.V.	Authorised	28/03/2006	Glycogen Storage Disease Type II