Miglustat Dipharma is a medicine used to treat adults with mild to moderate type-1 Gaucher disease.
Patients with this disease lack an enzyme that breaks down a type of fat called glucosylceramide. As a result, glucosylceramide builds up in different parts of the body, such as the spleen, liver and bones. Miglustat Dipharma is used in patients who cannot receive enzyme-replacement therapy.
Miglustat Dipharma is a ‘generic medicine’. This means that Miglustat Dipharma contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Zavesca.
Miglustat Dipharma : EPAR - Medicine overview (PDF/91.46 KB)
First published: 02/05/2019
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This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.
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18/02/2019 Miglustat Dipharma - EMEA/H/C/004904 -
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Miglustat Dipharma is indicated for the oral treatment of adult patients with mild to moderate type 1 Gaucher disease. Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable