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MYOZYME Powder for concentrate solution (2017)

Active ingredients: Alglucosidase alfa

Product Name and Form

Myozyme 50 mg powder for concentrate for solution for infusion.

Pharmaceutical form

Powder for concentrate for solution for infusion.

White to off-white powder.

Qualitative and Quantitative Composition

One vial contains 50 mg of alglucosidase alfa.

After reconstitution, the solution contains 5 mg of alglucosidase alfa* per ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ml.

* Human acid α-glucosidase is produced in Chinese hamster ovary cells (CHO) by recombinant DNA technology.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Alglucosidase alfa

Alglucosidase alfa is an enzyme replacement therapy orphan drug for treatment of Pompe disease (Glycogen storage disease type II), a rare lysosomal storage disorder (LSD). It is postulated that alglucosidase alfa will restore lysosomal GAA activity resulting in stabilisation or restoration of cardiac and skeletal muscle function (including respiratory muscles). Due to the bloodbrain barrier effect and the enzyme’s size, uptake of alglucosidase alfa in the central nervous system is unlikely.

List of excipients

Mannitol (E421)
Sodium dihydrogen phosphate monohydrate (E339)
Disodium phosphate heptahydrate (E339)
Polysorbate 80 (E433)

Pack sizes and Marketing

50 mg of powder in a vial (Type 1 glass) with a stopper (siliconised butyl) and a seal (aluminium) with a flip-off cap (plastic). Pack sizes of 1, 10 or 25 vials.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Genzyme Europe B.V., Gooimeer 10, NL-1411 DD Naarden, The Netherlands

Date of first authorisation: 29 March 2006
Date of latest renewal: 29 March 2011

Marketing authorization number:

EU/1/06/333/001-003