Genzyme Ireland Limited (manufacturing of the final product (fill/finish), batch control, packaging, labeling, location of authorized person, batch release)

The drug is intended for long-term enzyme replacement therapy in patients with confirmed Gaucher disease (non-neuropathic type 1 or chronic neuropathic type 3) who present with symptoms such as anemia, low platelet count, bone disease, or enlargement of the liver or spleen.

Dosage form: powder for preparation of concentrate for infusion solution

ATC: A16AB02